The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for Camera Cover With Tear Tip.
| Device ID | K940152 |
| 510k Number | K940152 |
| Device Name: | CAMERA COVER WITH TEAR TIP |
| Classification | Accessories, Photographic, For Endoscope (exclude Light Sources) |
| Applicant | HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Contact | Bonnie Beasley |
| Correspondent | Bonnie Beasley HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Product Code | FEM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-03 |
| Decision Date | 1994-10-28 |