• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back To Search Results
Device Classification Name latex patient examination glove
510(k) Number K951171
Device Name SCIPOTEX
Original Applicant
lot 1, jalan 3,
kawasan perusahaan bandar baru
salak tinggi, sepang selangor,  MY 43900
Original Contact ong g chee
Regulation Number880.6250
Classification Product Code
Date Received03/15/1995
Decision Date 04/13/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No