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 Bandage, Liquid
510(k) Number K971612
Device Name OSMO/PCA PILLOW WOUND DRESSING
Applicant
Procyte Corp.
12040 115th Ave. NE
Suite 210
Kirkland,  WA  98034 -6900
Applicant Contact PAUL KETTERIDGE
Correspondent
Procyte Corp.
12040 115th Ave. NE
Suite 210
Kirkland,  WA  98034 -6900
Correspondent Contact PAUL KETTERIDGE
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/02/1997
Decision Date 03/16/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-