The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for Sterile Tv Camera & Cord Cover.
| Device ID | K812405 |
| 510k Number | K812405 |
| Device Name: | STERILE TV CAMERA & CORD COVER |
| Classification | Camera, Surgical And Accessories |
| Applicant | HYDRO-MED PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KQM |
| CFR Regulation Number | 878.4160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-21 |
| Decision Date | 1981-10-20 |