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 K951473
Device Name ULTIMAX
Applicant
Wembley Rubber Products (M) Sdn Bhd
84,Jalan Raja Chulan
50200 Kuala Lumpur
Malaysia,  MY
Applicant Contact ONG G CHEE
Correspondent
Wembley Rubber Products (M) Sdn Bhd
84,Jalan Raja Chulan
50200 Kuala Lumpur
Malaysia,  MY
Correspondent Contact ONG G CHEE
Regulation Number878.4460
Classification Product Code
KGO  
Date Received03/30/1995
Decision Date 07/17/1995
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
-
-