PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K080093
Device Name PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
Applicant
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Applicant Contact terrence e sullivan
Correspondent
GYRUS ACMI, INC.
136 turnpike rd.
southborough, 
MA 
01772

Correspodent Contact terrence e sullivan
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
HET  
Date Received 01/14/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No