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 K970693
Device Name ACRYDERM GEL WOUND DRESSING
Applicant
Acrymed, Inc.
12232 SW Garden Pl.
Portland,  OR  97223
Applicant Contact BRUCE GIBBINS
Correspondent
Acrymed, Inc.
12232 SW Garden Pl.
Portland,  OR  97223
Correspondent Contact BRUCE GIBBINS
Classification Product Code
MGQ  
Date Received02/25/1997
Decision Date 03/21/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-