The following data is part of a premarket notification filed by Remington Medical, Inc. with the FDA for Remington Medical Dispos Tear-away Vasc Intro Set.
| Device ID | K932370 |
| 510k Number | K932370 |
| Device Name: | REMINGTON MEDICAL DISPOS TEAR-AWAY VASC INTRO SET |
| Classification | Introducer, Catheter |
| Applicant | REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Contact | Frederick L.aycock |
| Correspondent | Frederick L.aycock REMINGTON MEDICAL, INC. 8601 DUNWOODY PL., SUITE 510 Atlanta, GA 30350 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-14 |
| Decision Date | 1993-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20813079020213 | K932370 | 000 |
| 10813079020209 | K932370 | 000 |
| 20813079020190 | K932370 | 000 |
| 10813079020186 | K932370 | 000 |
| 10813079020179 | K932370 | 000 |
| 10813079020162 | K932370 | 000 |