The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Syrigene Pre-filled Syringe.
| Device ID | K935669 |
| 510k Number | K935669 |
| Device Name: | SYRIGENE PRE-FILLED SYRINGE |
| Classification | Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) |
| Applicant | REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
| Contact | Patrick J Lamb |
| Correspondent | Patrick J Lamb REGULATORY & MARKETING SERVICES, INC. P.O. BOX 2010 Palm Harbor, FL 34682 |
| Product Code | JDL |
| Subsequent Product Code | FOZ |
| Subsequent Product Code | LYY |
| CFR Regulation Number | 888.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1994-02-18 |