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 Gown, Surgical
510(k) Number K934608
Device Name BARRIER FABRIC 450 SURGICAL GOWN
Applicant
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Applicant Contact LINDA G HILL
Correspondent
Johnson & Johnson Medical, Inc.
P.O. Box 90130
Arlington,  TX  76004
Correspondent Contact LINDA G HILL
Regulation Number878.4040
Classification Product Code
FYA  
Date Received09/27/1993
Decision Date 04/11/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-