CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K103840
Device Name CURVED / STRAIGHT / MINI / HOOK SCISSOR TIP, DISSECTOR TIP, SURGICAL HANDLE
Applicant
FLEXBAR MACHINE CORP.
30 northport road
sound beach, 
NY 
11764

Applicant Contact stephen t mlcoch
Correspondent
FLEXBAR MACHINE CORP.
30 northport road
sound beach, 
NY 
11764

Correspodent Contact stephen t mlcoch
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 12/10/2010
Decision Date 02/28/2011
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