POWRSYRINGE INJECTOR


Device Classification Name

syringe, piston

510(k) Number K072318
Device Name POWRSYRINGE INJECTOR
Applicant
PINYONS MEDICAL TECHNOLOGY, INC.
5010 heuga ct.
park city, 
UT 
84098

Applicant Contact shawn p fojtik
Regulation Number 880.5860
Classification Product Code
FMF  
Date Received 08/20/2007
Decision Date 09/21/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No