The following data is part of a premarket notification filed by Regulatory & Marketing Services, Inc. with the FDA for Syrigene Acetic Acid Pre-filledsyringe.
| Device ID | K935643 |
| 510k Number | K935643 |
| Device Name: | SYRIGENE ACETIC ACID PRE-FILLEDSYRINGE |
| Classification | Accessories, Catheter, G-u |
| 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 | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-26 |
| Decision Date | 1994-06-10 |