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 K880869
Device Name MEDI-LET
Applicant
MEDICORE, INC.
2201 W. 76TH ST.
HIALEAH,  FL  33016
Applicant Contact DANIEL J CHIODO
Correspondent
MEDICORE, INC.
2201 W. 76TH ST.
HIALEAH,  FL  33016
Correspondent Contact DANIEL J CHIODO
Regulation Number878.4850
Classification Product Code
FMK  
Date Received03/01/1988
Decision Date 03/21/1988
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
-
-