The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Safe Connect Surgical Cable (s-101-97/s-201-97/fl-601-97).
| Device ID | K971968 |
| 510k Number | K971968 |
| Device Name: | SAFE CONNECT SURGICAL CABLE (S-101-97/S-201-97/FL-601-97) |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta, GA 30202 |
| Contact | Don Rosvold |
| Correspondent | Don Rosvold REMINGTON MEDICAL, INC. 6830 MEADOWRIDGE COURT Alpharetta, GA 30202 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-28 |
| Decision Date | 1997-07-23 |