The following data is part of a premarket notification filed by Novar Medical Industries with the FDA for Endowash.
| Device ID | K915620 |
| 510k Number | K915620 |
| Device Name: | ENDOWASH |
| Classification | Accessories, Cleaning, For Endoscope |
| Applicant | NOVAR MEDICAL INDUSTRIES 627 EAGLE ROCK AVE. STE. 136 W. Orange, NJ 07052 |
| Contact | Craig Manders |
| Correspondent | Craig Manders NOVAR MEDICAL INDUSTRIES 627 EAGLE ROCK AVE. STE. 136 W. Orange, NJ 07052 |
| Product Code | FEB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1993-12-02 |