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 Protector, Skin Pressure
510(k) Number K951325
Device Name COMFEEL PLUS PRESSURE RELIEF DRESSING
Applicant
Richard Hamer Assoc., Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Applicant Contact RICHARD A HAMER
Correspondent
Richard Hamer Assoc., Inc.
P.O. Box 16598
Fort Worth,  TX  76162
Correspondent Contact RICHARD A HAMER
Regulation Number880.6450
Classification Product Code
FMP  
Date Received03/23/1995
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-