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 K905438
Device Name NORMLGEL PROTECTIVE WOUND GEL
Applicant
Scott Health Care
Scott Plz. Iii
Philadelphia,  PA  19113
Applicant Contact RICHARD HAMER
Correspondent
Scott Health Care
Scott Plz. Iii
Philadelphia,  PA  19113
Correspondent Contact RICHARD HAMER
Classification Product Code
FRO  
Date Received12/04/1990
Decision Date 04/01/1991
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-