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 K895372
Device Name X-RAY DETECTABLE GAUZE SPONGE
Applicant
Keilei Intl., Inc.
Hamilton Business Park 88
Franklin Rd.
Dover,  NJ  07901
Applicant Contact ALBERT SHEN
Correspondent
Keilei Intl., Inc.
Hamilton Business Park 88
Franklin Rd.
Dover,  NJ  07901
Correspondent Contact ALBERT SHEN
Regulation Number878.4450
Classification Product Code
GDY  
Date Received08/29/1989
Decision Date 11/03/1989
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
-
-