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 Dress, Surgical
510(k) Number K912790
Device Name SURGICAL GOWN
Applicant
Unicor Federal Dept. of Justice
Fed.Corectional Institution
Alderson,  WV  24910
Applicant Contact DAVID A.DIXON
Correspondent
Unicor Federal Dept. of Justice
Fed.Corectional Institution
Alderson,  WV  24910
Correspondent Contact DAVID A.DIXON
Regulation Number878.4040
Classification Product Code
FYE  
Date Received06/25/1991
Decision Date 09/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-