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

Filler, Bone Void, Calcium Compound

REGENERATION TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Regeneration Technologies, Inc. with the FDA for Cancello-pure Bone Wedge, 12mm Evans Or 6mm Cotton.

Pre-market Notification Details

Device IDK072327
510k NumberK072327
Device Name:CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON
ClassificationFiller, Bone Void, Calcium Compound
Applicant REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua,  FL  32616 -2650
ContactLisa Simpson
CorrespondentLisa Simpson
REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua,  FL  32616 -2650
Product CodeMQV  
CFR Regulation Number888.3045 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-08-20
Decision Date2007-10-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840420136947 K072327 000
00840420136930 K072327 000

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