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, Hydrogel W/Drug And/Or Biologic
510(k) Number K953853
Device Name IAMIN GEL WOUND DRESSING
Applicant
Procyte Corp.
12040 115th Ave. NE
Suite 210
Kirkland,  WA  98034
Applicant Contact DAVID J DEMPSEY
Correspondent
Procyte Corp.
12040 115th Ave. NE
Suite 210
Kirkland,  WA  98034
Correspondent Contact DAVID J DEMPSEY
Classification Product Code
MGQ  
Date Received08/16/1995
Decision Date 02/05/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-