MOUNTABLE ENDOSCOPIC BLADE


Device Classification Name

knife, surgical

510(k) Number K080133
Device Name MOUNTABLE ENDOSCOPIC BLADE
Applicant
A.M. SURGICAL, INC.
290 east main st. suite 200
smithtown, 
NY 
11787

Applicant Contact vincent pascale
Correspondent
A.M. SURGICAL, INC.
290 east main st. suite 200
smithtown, 
NY 
11787

Correspodent Contact vincent pascale
Regulation Number 878.4800
Classification Product Code
EMF  
Date Received 01/18/2008
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No