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 Surgeon'S Gloves
510(k) Number K935464
Device Name COMFIT
Applicant
Wembley Rubber Products (M) Sdn Bhd
Peru Bandar Baru Salak Tinggi
43900 Sepang
Selangor, Malaysia,  MY
Applicant Contact ONG GHEE CHEE
Correspondent
Wembley Rubber Products (M) Sdn Bhd
Peru Bandar Baru Salak Tinggi
43900 Sepang
Selangor, Malaysia,  MY
Correspondent Contact ONG GHEE CHEE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received11/12/1993
Decision Date 05/09/1994
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
-
-