The following data is part of a premarket notification filed by Ipco Corp. with the FDA for Endex Broach, Endodontic.
Device ID | K800292 |
510k Number | K800292 |
Device Name: | ENDEX BROACH, ENDODONTIC |
Classification | Broach, Endodontic |
Applicant | IPCO CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EKW |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-11 |
Decision Date | 1980-02-19 |