RESORBABLE CRANIAL CLAMPS


Device Classification Name

cover, burr hole

510(k) Number K021408
Device Name RESORBABLE CRANIAL CLAMPS
Original Applicant
SYNTHES (USA)
1690 russell rd.
paoli, 
PA 
19301

Original Contact matthew m hull
Regulation Number 882.5250
Classification Product Code
GXR  
Date Received 05/03/2002
Decision Date 07/29/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No