The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Rmi Vascular Tourniquet Kit.
| Device ID | K910221 |
| 510k Number | K910221 |
| Device Name: | RMI VASCULAR TOURNIQUET KIT |
| Classification | Clamp, Vascular |
| Applicant | RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Contact | Michael N Kelly |
| Correspondent | Michael N Kelly RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City, UT 84119 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-17 |
| Decision Date | 1991-05-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103041798 | K910221 | 000 |