The following data is part of a premarket notification filed by Intra-lock International, Inc. with the FDA for Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,rp-1, Rg-1.
| Device ID | K082419 |
| 510k Number | K082419 |
| Device Name: | REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INTRA-LOCK INTERNATIONAL, INC. 6560 W. ROGERS CIRCLE SUITE 24 Boca Raton, FL 33487 |
| Contact | Jeffrey Sakoff |
| Correspondent | Jeffrey Sakoff INTRA-LOCK INTERNATIONAL, INC. 6560 W. ROGERS CIRCLE SUITE 24 Boca Raton, FL 33487 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-22 |
| Decision Date | 2009-05-27 |
| Summary: | summary |