The following data is part of a premarket notification filed by Trueline Instruments, Inc. with the FDA for Knife, Ophthalmic.
Device ID | K871285 |
510k Number | K871285 |
Device Name: | KNIFE, OPHTHALMIC |
Classification | Knife, Ophthalmic |
Applicant | TRUELINE INSTRUMENTS, INC. P.O. BOX 26784 Tucson, AZ 85726 |
Contact | M Haworth,jr |
Correspondent | M Haworth,jr TRUELINE INSTRUMENTS, INC. P.O. BOX 26784 Tucson, AZ 85726 |
Product Code | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-31 |
Decision Date | 1987-04-27 |