The following data is part of a premarket notification filed by Ethox Corp. with the FDA for Surgi-cuf Sterile/non-sterile Disposable.
| Device ID | K883977 |
| 510k Number | K883977 |
| Device Name: | SURGI-CUF STERILE/NON-STERILE DISPOSABLE |
| Classification | Blood Pressure Cuff |
| Applicant | ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Contact | F Jankowski |
| Correspondent | F Jankowski ETHOX CORP. 251 SENECA ST. Buffalo, NY 14204 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-20 |
| Decision Date | 1989-02-10 |