The following data is part of a premarket notification filed by Hydro-med Products, Inc. with the FDA for Surgical Microscope Drape.
| Device ID | K944198 |
| 510k Number | K944198 |
| Device Name: | SURGICAL MICROSCOPE DRAPE |
| Classification | Cover, Barrier, Protective |
| Applicant | HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Product Code | MMP |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-08-29 |
| Decision Date | 1994-11-27 |