The following data is part of a premarket notification filed by Eder Instrument Co, Inc. with the FDA for Surgical Knives & Probes.
Device ID | K802479 |
510k Number | K802479 |
Device Name: | SURGICAL KNIVES & PROBES |
Classification | Probe |
Applicant | EDER INSTRUMENT CO, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HXB |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-10-07 |
Decision Date | 1980-10-31 |