The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Disposable Extension Cable Fas-loc Fl-601.
| Device ID | K940467 |
| 510k Number | K940467 |
| Device Name: | REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601 |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Contact | Fredrick L Aycock |
| Correspondent | Fredrick L Aycock REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-11-01 |