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 K000745
Device Name SENSI GRIP LATEX EXAMINATION GLOVE, POWDERED CONTAINS 200 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
Applicant
TILLOTSON HEALTHCARE CORP.
360 ROUTE 101
BEDFORD,  NH  03110 -5030
Applicant Contact THOMAS N TILLOTSON
Correspondent
TILLOTSON HEALTHCARE CORP.
360 ROUTE 101
BEDFORD,  NH  03110 -5030
Correspondent Contact THOMAS N TILLOTSON
Regulation Number880.6250
Classification Product Code
LYY  
Date Received03/08/2000
Decision Date 05/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-