Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name dressing, wound, drug
510(k) Number K042400
Device Name MUCOTROL CONCENTRATED ORAL GEL WAFER
Applicant
BELCHER PHARMACEUTICALS, INC.
12393 BELCHER ROAD
SUITE 420
LARGO,  FL  33773
Applicant Contact KOTHA SEKHARAM
Correspondent
BELCHER PHARMACEUTICALS, INC.
12393 BELCHER ROAD
SUITE 420
LARGO,  FL  33773
Correspondent Contact KOTHA SEKHARAM
Classification Product Code
FRO  
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
Recalls CDRH Recalls
-
-