The following data is part of a premarket notification filed by Today's Machining & Design, Inc. with the FDA for Disc Needle Set #tx-8220.
Device ID | K823676 |
510k Number | K823676 |
Device Name: | DISC NEEDLE SET #TX-8220 |
Classification | File, Bone, Surgical |
Applicant | TODAY'S MACHINING & DESIGN, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EMI |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-07 |
Decision Date | 1983-01-09 |