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 Polymer Patient Examination Glove
510(k) Number K950033
Device Name POLYDERM
Applicant
Wilshire Technologies
5441 Avenida Encinas
Suite A
Carlsbadd,  CA  92008
Applicant Contact ALAN SEACORD
Correspondent
Wilshire Technologies
5441 Avenida Encinas
Suite A
Carlsbadd,  CA  92008
Correspondent Contact ALAN SEACORD
Regulation Number880.6250
Classification Product Code
LZA  
Date Received01/04/1995
Decision Date 04/04/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-