The following data is part of a premarket notification filed by Gabriel Medical, Inc. with the FDA for Gabriel Ureteral Illuminator System.
| Device ID | K940019 |
| 510k Number | K940019 |
| Device Name: | GABRIEL URETERAL ILLUMINATOR SYSTEM |
| Classification | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Applicant | GABRIEL MEDICAL, INC. ATTN: MARY M. MCNAMARA 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | Mary M Mcnamara |
| Correspondent | Mary M Mcnamara GABRIEL MEDICAL, INC. ATTN: MARY M. MCNAMARA 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | FCS |
| CFR Regulation Number | 876.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1994-05-02 |