HEMORRHAGE OCCLUDER PIN

Device Classification Name

staple, implantable

510(k) Number K040109
Device Name HEMORRHAGE OCCLUDER PIN
Applicant
TOOLS FOR SURGERY, LLC
1339 stony brook road
stony brook, 
NY 
11790

Applicant Contact arnold r leiboff
Correspondent
TOOLS FOR SURGERY, LLC
1339 stony brook road
stony brook, 
NY 
11790

Correspodent Contact arnold r leiboff
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 01/20/2004
Decision Date 03/25/2004
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