GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)


Device Classification Name

coagulator-cutter, endoscopic, bipolar (and accessories)

510(k) Number K111059
Device Name GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)
Applicant
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Applicant Contact lorraine calzetta
Correspondent
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Correspodent Contact lorraine calzetta
Regulation Number 884.4150
Classification Product Code
HIN  
Date Received 04/18/2011
Decision Date 09/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No