SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K010710
Device Name SEEDLING ENTERPRISES LLC, COOL TEC MONOPOLAR AND BIPOLAR REUSABLE ELECTRODES
Original Applicant
SEEDLING ENTERPRISES. LLC.
7 tiffany trial
hopkinton, 
MA 
01748

Original Contact debbie iampietro
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 03/09/2001
Decision Date 05/18/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized