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 K965005
Device Name IAMIN IMPREGNATED GAUZE DRESSING
Applicant
PROCYTE CORP.
12040 115TH AVENUE NE
SUITE 210
KIRKLAND,  WA  98034
Applicant Contact PAUL KETTERIDGE
Correspondent
PROCYTE CORP.
12040 115TH AVENUE NE
SUITE 210
KIRKLAND,  WA  98034
Correspondent Contact PAUL KETTERIDGE
Classification Product Code
MGQ  
Date Received12/16/1996
Decision Date 02/24/1997
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-