The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Disposable Surgical Extension Cable Model S-101.
| Device ID | K922009 |
| 510k Number | K922009 |
| Device Name: | DISPOSABLE SURGICAL EXTENSION CABLE MODEL S-101 |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | REMINGTON MEDICAL, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Contact | Carolann Kotula-cook |
| Correspondent | Carolann Kotula-cook REMINGTON MEDICAL, INC. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BLVD., SUITE 301 Great Neck, NY 11021 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-29 |
| Decision Date | 1993-02-25 |