DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K110924
Device Name DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPS
Applicant
SYNERGETICS, INC
3845 corporate centre drive
o’fallon, 
MO 
63368

Applicant Contact gary oliveros
Correspondent
SYNERGETICS, INC
3845 corporate centre drive
o’fallon, 
MO 
63368

Correspodent Contact gary oliveros
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 04/04/2011
Decision Date 12/07/2011
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