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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oral Wound Dressing
510(k) Number K042400
Device Name MUCOTROL CONCENTRATED ORAL GEL WAFER
Applicant
Belcher Pharmaceuticals, Inc.
12393 Belcher Rd.
Suite 420
Largo,  FL  33773
Applicant Contact KOTHA SEKHARAM
Correspondent
Belcher Pharmaceuticals, Inc.
12393 Belcher Rd.
Suite 420
Largo,  FL  33773
Correspondent Contact KOTHA SEKHARAM
Classification Product Code
OLR  
Date Received09/03/2004
Decision Date 11/24/2004
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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