SURGASSIST FLEXSHAFT 2, MODEL FS2 14


Device Classification Name

staple, implantable

510(k) Number K021249
Device Name SURGASSIST FLEXSHAFT 2, MODEL FS2 14
Original Applicant
POWER MEDICAL INTERVENTIONS, INC.
110 union square dr.
new hope, 
PA 
18938 -1364

Original Contact barbara j whitman
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 04/19/2002
Decision Date 05/15/2002
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