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 Gauze/Sponge, Internal
510(k) Number K864298
Device Name ZENEX MEDICAL, INC. GAUZE SPONGES
Applicant
Zenex Medical, Inc.
2940 N. Halsted St.
Chicago,  IL  60657
Applicant Contact ROBERT G JUNG
Correspondent
Zenex Medical, Inc.
2940 N. Halsted St.
Chicago,  IL  60657
Correspondent Contact ROBERT G JUNG
Classification Product Code
EFQ  
Date Received10/31/1986
Decision Date 12/04/1986
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-