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, X-Ray Detectable
510(k) Number K854714
Device Name X-RAY DETECTABLE COTTON BALLS
Applicant
AMERICAN SILK SUTURES, INC.
P.O. BOX 370
LEDYARD,  CT  06339
Correspondent
AMERICAN SILK SUTURES, INC.
P.O. BOX 370
LEDYARD,  CT  06339
Regulation Number878.4450
Classification Product Code
GDY  
Date Received11/22/1985
Decision Date 12/17/1985
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
Recalls CDRH Recalls
-
-