E-VAC


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K073455
Device Name E-VAC
Applicant
NEW LEAF MEDICAL, INC.
11476 hawke rd
suite #c
columbia station, 
OH 
44028

Applicant Contact richard t nock
Correspondent
NEW LEAF MEDICAL, INC.
11476 hawke rd
suite #c
columbia station, 
OH 
44028

Correspodent Contact richard t nock
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 12/10/2007
Decision Date 03/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General Hospital

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No