The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Fastube Nerve Regeneration Device.
Device ID | K850785 |
510k Number | K850785 |
Device Name: | FASTUBE NERVE REGENERATION DEVICE |
Classification | Cuff, Nerve |
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 | JXI |
CFR Regulation Number | 882.5275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-26 |
Decision Date | 1985-07-10 |