DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE


Device Classification Name

syringe, piston

510(k) Number K103736
Device Name DMC MEDICAL SINGLE-USE POLYCARBONATE SYRINGE
Applicant
DMC MEDICAL LTD.
944 north main street
bountiful, 
UT 
84010

Applicant Contact tracy best
Correspondent
DMC MEDICAL LTD.
944 north main street
bountiful, 
UT 
84010

Correspodent Contact tracy best
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 12/22/2010
Decision Date 06/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No