The following data is part of a premarket notification filed by Artiberia with the FDA for 830/4 To 848/7 Various Types Chisels.
Device ID | K851715 |
510k Number | K851715 |
Device Name: | 830/4 TO 848/7 VARIOUS TYPES CHISELS |
Classification | Chisel, Bone, 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 | EML |
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 |