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 Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K931827
Device Name CLEANLET, CLEANLET XL & KIDS
Applicant
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Applicant Contact MARK J GAINOR
Correspondent
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Correspondent Contact MARK J GAINOR
Regulation Number878.4850
Classification Product Code
FMK  
Date Received04/08/1993
Decision Date 09/13/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-