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 K041665
Device Name L1-PRO SYSTEM
Applicant
PELIKAN TECHNOLOGIES, INC
1072 EAST MEADOW CIRCLE
PALO ALTO,  CA  94303
Applicant Contact JACK S GREEN
Correspondent
PELIKAN TECHNOLOGIES, INC
1072 EAST MEADOW CIRCLE
PALO ALTO,  CA  94303
Correspondent Contact JACK S GREEN
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/18/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-