The following data is part of a premarket notification filed by Artiberia with the FDA for 820/1 To 820/51 Various Types Bone Rongeurs.
Device ID | K851714 |
510k Number | K851714 |
Device Name: | 820/1 TO 820/51 VARIOUS TYPES BONE RONGEURS |
Classification | Chisel, Osteotome, Surgical |
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 | EMM |
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 |