The following data is part of a premarket notification filed by Allosource, Inc. with the FDA for Allofuse Gel And Putty.
| Device ID | K071849 |
| 510k Number | K071849 |
| Device Name: | ALLOFUSE GEL AND PUTTY |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ALLOSOURCE, INC. 6278 S. TROY CIRCLE Centennial, CO 80111 |
| Contact | Pamela Vetter |
| Correspondent | Pamela Vetter ALLOSOURCE, INC. 6278 S. TROY CIRCLE Centennial, CO 80111 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-05 |
| Decision Date | 2008-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867084209 | K071849 | 000 |
| 00810076560380 | K071849 | 000 |
| 00810076560649 | K071849 | 000 |
| 00810076560656 | K071849 | 000 |
| 00810076560663 | K071849 | 000 |
| 00810076560670 | K071849 | 000 |
| 00810076560687 | K071849 | 000 |
| 00810076560694 | K071849 | 000 |
| 00887517970473 | K071849 | 000 |
| 00887517970497 | K071849 | 000 |
| 00887517971517 | K071849 | 000 |
| 00888867084148 | K071849 | 000 |
| 00888867084155 | K071849 | 000 |
| 00888867084162 | K071849 | 000 |
| 00888867084179 | K071849 | 000 |
| 00888867084186 | K071849 | 000 |
| 00888867084193 | K071849 | 000 |
| 00810076560007 | K071849 | 000 |