IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS


Device Classification Name

staple, implantable

510(k) Number K073148
Device Name IDRIVES, IDRIVEC, IDRIVEF WITH VASCULAR INDICATIONS
Applicant
POWER MEDICAL INTERVENTIONS, INC.
2021 cabot blvd.
langhorne, 
PA 
19047

Applicant Contact barbara j whitman
Correspondent
POWER MEDICAL INTERVENTIONS, INC.
2021 cabot blvd.
langhorne, 
PA 
19047

Correspodent Contact barbara j whitman
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 11/08/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No