The following data is part of a premarket notification filed by Un-i-med, Inc. with the FDA for Endoscopic Accessory.
| Device ID | K945191 |
| 510k Number | K945191 |
| Device Name: | ENDOSCOPIC ACCESSORY |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | UN-I-MED, INC. 10401 BELCHER RD. Largo, FL 34647 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville UN-I-MED, INC. 10401 BELCHER RD. Largo, FL 34647 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-24 |
| Decision Date | 1995-05-03 |