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 K940931
Device Name ASEP(TM) PLUS SURGICAL GOWN
Applicant
Angelica Uniform Group, Inc.
P.O. Box 466
St Louis,  MO  63166
Applicant Contact HOWARD M ZINS
Correspondent
Angelica Uniform Group, Inc.
P.O. Box 466
St Louis,  MO  63166
Correspondent Contact HOWARD M ZINS
Regulation Number878.4040
Classification Product Code
FYA  
Date Received02/28/1994
Decision Date 07/26/1994
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
-
-