The following data is part of a premarket notification filed by I M, Inc. with the FDA for Syringe Prefilled With Water.
| Device ID | K881363 |
| 510k Number | K881363 |
| Device Name: | SYRINGE PREFILLED WITH WATER |
| Classification | Catheter, Urological |
| Applicant | I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Contact | Amir Porat |
| Correspondent | Amir Porat I M, INC. P.O. BOX 658 Fairfield, NJ 07004 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-31 |
| Decision Date | 1988-06-23 |