The following data is part of a premarket notification filed by Artiberia with the FDA for 29-140 To 29-196 Various Bone Chisels (osteotomes,.
Device ID | K851788 |
510k Number | K851788 |
Device Name: | 29-140 TO 29-196 VARIOUS BONE CHISELS (OSTEOTOMES, |
Classification | Chisel, Surgical, Manual |
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 | FZO |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-06-20 |