CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS


Device Classification Name

plate, bone

510(k) Number K002798
Device Name CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS
Original Applicant
Codman & Shurtleff, Inc.
325 paramount dr.
raynham, 
MA 
02767 -0350

Original Contact james m flaherty
Regulation Number 872.4760
Classification Product Code
JEY  
Date Received 09/07/2000
Decision Date 12/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No