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 Latex Patient Examination Glove
510(k) Number K900368
Device Name P2/CHEMO PLUS GLOVES
Applicant
Biosafety Systems, Inc.
8380 Camino Santa Fe
San Diego,  CA  92121
Applicant Contact HANK KRAUS
Correspondent
Biosafety Systems, Inc.
8380 Camino Santa Fe
San Diego,  CA  92121
Correspondent Contact HANK KRAUS
Regulation Number880.6250
Classification Product Code
LYY  
Date Received01/26/1990
Decision Date 03/08/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-