CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON


Device Classification Name

filler, bone void, calcium compound

510(k) Number K072327
Device Name CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
Applicant
REGENERATION TECHNOLOGIES, INC.
11621 research cir.
p.o. box 2650
alachua, 
FL 
32616 -2650

Applicant Contact lisa simpson
Correspondent
REGENERATION TECHNOLOGIES, INC.
11621 research cir.
p.o. box 2650
alachua, 
FL 
32616 -2650

Correspodent Contact lisa simpson
Regulation Number 888.3045
Classification Product Code
MQV  
Date Received 08/20/2007
Decision Date 10/24/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No