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Article: CDRH promo untitled letters.
- Article from:
- Warning Letter Bulletin
- Article date:
- September 23, 2002
CopyrightCOPYRIGHT 2002 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The following untitled letters were issued by the Promotion and Advertising Staff of the Center for Devices, Office of Compliance (CDRH-OC) in 2001. Copies of these letters are available to subscribers from RECORD-RETRIEVE for $7 plus retrieval.
11919W
CeraMed Dental, L.L.C., Lakewood, CO, Oct. 18, 2001 (CDRH-OC). The agency took issue with a promotional flyer for the company's PepGen P-15 bone filling material which stated: "For additional containment of PepGen P-15 FLOW, a fast resorbing barrier membrane may be used (such as Gelfoam[R])." Since Gelfoam is a hemostatic agent which has not been cleared as a barrier membrane, FDA stated the parenthetical ...
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Article: CDRH UNTITLED LETTERS: 7640W.
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...London International Group, Dothan, AL, June 12, 1998 (CDRH-OC). FDA noted that the company's subsidiary, Regent Medical Products, had agreed to stop distributing literature making prohibited ...
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