The following data is part of a premarket notification filed by Spectrum/hydro-med Products, Inc. with the FDA for Sterile Esmarch Bandage.
| Device ID | K881176 |
| 510k Number | K881176 |
| Device Name: | STERILE ESMARCH BANDAGE |
| Classification | Tourniquet, Nonpneumatic |
| Applicant | SPECTRUM/HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Contact | Bonnie Beasley |
| Correspondent | Bonnie Beasley SPECTRUM/HYDRO-MED PRODUCTS, INC. 2930 LADYBIRD LN. Dallas, TX 75220 |
| Product Code | GAX |
| CFR Regulation Number | 878.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-04-11 |