The following data is part of a premarket notification filed by Steridyne Corp. with the FDA for Clean Cuff Blood Pressure Cuff Liner.
| Device ID | K925352 |
| 510k Number | K925352 |
| Device Name: | CLEAN CUFF BLOOD PRESSURE CUFF LINER |
| Classification | Blood Pressure Cuff |
| Applicant | STERIDYNE CORP. 3725 INVESTMENT LN. Riviera Beach, FL 33404 |
| Contact | Mark P Poncy |
| Correspondent | Mark P Poncy STERIDYNE CORP. 3725 INVESTMENT LN. Riviera Beach, FL 33404 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1993-01-12 |