The following data is part of a premarket notification filed by Artiberia with the FDA for 27-230 To 27-234 Various Cast Breakers, Wolf.
Device ID | K851786 |
510k Number | K851786 |
Device Name: | 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF |
Classification | Instrument, Cast Application/removal, 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 | LGG |
CFR Regulation Number | 888.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-07-09 |