SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)


codes

Device Classification Name

filler, bone void, calcium compound

510(k) Number K002362
Device Name SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS)
Original Applicant
SYNTHES (USA)
p.o. box 1766
1690 russell road
paoli, 
PA 
19301 -1222

Original Contact bonnie j smith
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 08/03/2000
Decision Date 11/01/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No