The following data is part of a premarket notification filed by Artiberia with the FDA for 1/310, 1-320 Percussion Hammers,taylor, Dejerine.
Device ID | K851748 |
510k Number | K851748 |
Device Name: | 1/310, 1-320 PERCUSSION HAMMERS,TAYLOR, DEJERINE |
Classification | Percussor |
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 | GWZ |
CFR Regulation Number | 882.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-06-13 |