INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES


Device Classification Name

syringe, piston

510(k) Number K081436
Device Name INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES
Applicant
INVIRO MEDICAL DEVICES, INC.
1755 north brown road
suite 150
lawrenceville, 
GA 
30043

Applicant Contact robert n clark
Correspondent
INVIRO MEDICAL DEVICES, INC.
1755 north brown road
suite 150
lawrenceville, 
GA 
30043

Correspodent Contact robert n clark
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 05/21/2008
Decision Date 10/22/2008
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