The following data is part of a premarket notification filed by Artiberia with the FDA for 13-550,13-560 Wescott Scossors (eye).
Device ID | K851768 |
510k Number | K851768 |
Device Name: | 13-550,13-560 WESCOTT SCOSSORS (EYE) |
Classification | Scissors, Ophthalmic |
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 | HNF |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-04-25 |
Decision Date | 1985-06-20 |