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 K902430
Device Name GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD
Applicant
HERAEUS KULZER, INC.
DIAGNOSTICS DIVISION
P.O. BOX 70
ELKHART,  IN  46515
Applicant Contact M SAVOL
Correspondent
HERAEUS KULZER, INC.
DIAGNOSTICS DIVISION
P.O. BOX 70
ELKHART,  IN  46515
Correspondent Contact M SAVOL
Regulation Number878.4850
Classification Product Code
FMK  
Date Received05/31/1990
Decision Date 08/02/1990
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
Predetermined Change
Control Plan Authorized		 No
-
-