The following data is part of a premarket notification filed by Artiberia with the FDA for 37-610 To 37-880 Various Ophthal-forceps.
Device ID | K851791 |
510k Number | K851791 |
Device Name: | 37-610 TO 37-880 VARIOUS OPHTHAL-FORCEPS |
Classification | Forceps, 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 | HNR |
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 | 1985-05-30 |