GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES


definition

Device Classification Name

syringe, piston

510(k) Number K002569
Device Name GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES
Original Applicant
MALGAM ENT., INC.
2 clarence pl., #12
san francisco, 
CA 
94107 -0509

Original Contact michael l gamble
Regulation Number 880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received 08/18/2000
Decision Date 12/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No