The following data is part of a premarket notification filed by Artiberia with the FDA for 680/1 To 785/2 Various Types & Sizes Of Root Eleva.
Device ID | K851713 |
510k Number | K851713 |
Device Name: | 680/1 TO 785/2 VARIOUS TYPES & SIZES OF ROOT ELEVA |
Classification | Elevator, Surgical, Dental |
Applicant | ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
Contact | Gil M Sanchez |
Correspondent | Gil M Sanchez ARTIBERIA 4518 LOS RANCHITOS San Antonio, TX 78233 |
Product Code | EMJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-06-11 |