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 And Burn, Occlusive
510(k) Number K012997
Device Name COLLATEK FOAM
Applicant
Biocore Medical Technologies, Inc.
11800 Tech Rd.,
Suite # 240
Silver Spring,  MD  20904
Applicant Contact AJAY KUMAR
Correspondent
Biocore Medical Technologies, Inc.
11800 Tech Rd.,
Suite # 240
Silver Spring,  MD  20904
Correspondent Contact AJAY KUMAR
Classification Product Code
MGP  
Date Received09/06/2001
Decision Date 10/25/2001
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
-
-