The following data is part of a premarket notification filed by Sherman Ophthalmic Supplies, Inc. with the FDA for Mos-iii.
Device ID | K915873 |
510k Number | K915873 |
Device Name: | MOS-III |
Classification | System, Nuclear Magnetic Resonance Imaging |
Applicant | SHERMAN OPHTHALMIC SUPPLIES, INC. 428 S. BREA BLVD. STE. #B Brea, CA 92621 |
Contact | David Kirschen |
Correspondent | David Kirschen SHERMAN OPHTHALMIC SUPPLIES, INC. 428 S. BREA BLVD. STE. #B Brea, CA 92621 |
Product Code | LNH |
CFR Regulation Number | 892.1000 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-05 |
Decision Date | 1992-03-16 |