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.
| Device ID | K072327 |
| 510k Number | K072327 |
| Device Name: | CANCELLO-PURE BONE WEDGE, 12MM EVANS OR 6MM COTTON |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Contact | Lisa Simpson |
| Correspondent | Lisa Simpson REGENERATION TECHNOLOGIES, INC. 11621 RESEARCH CIR. P.O. BOX 2650 Alachua, FL 32616 -2650 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-20 |
| Decision Date | 2007-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840420136947 | K072327 | 000 |
| 00840420136930 | K072327 | 000 |