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, Isolation, Surgical
510(k) Number K970814
Device Name NON-STERILE ISOLATION GOWN
Applicant
American Seal Co.
25029 Viking St.
Hayward,  CA  94545
Applicant Contact JOSEPH TUNG
Correspondent
American Seal Co.
25029 Viking St.
Hayward,  CA  94545
Correspondent Contact JOSEPH TUNG
Regulation Number878.4040
Classification Product Code
FYC  
Date Received03/06/1997
Decision Date 05/27/1997
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
-
-