IDRIVES, IDRIVEC, IDRIVEF


Device Classification Name

staple, implantable

510(k) Number K073001
Device Name IDRIVES, IDRIVEC, IDRIVEF
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 10/24/2007
Decision Date 12/18/2007
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

Recalls CDRH Recalls