The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Shutt Precision Probes.
Device ID | K840558 |
510k Number | K840558 |
Device Name: | SHUTT PRECISION PROBES |
Classification | Probe |
Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HXB |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-08 |
Decision Date | 1984-04-25 |