The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Sussman Four Mirror Hand Held Gonioprism.
Device ID | K862024 |
510k Number | K862024 |
Device Name: | SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM |
Classification | Prism, Gonioscopic |
Applicant | OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
Contact | Tamsin J Erickson |
Correspondent | Tamsin J Erickson OCULAR INSTRUMENTS, INC. 12100 NORTHUP WAY SUITE D Bellevue, WA 98005 |
Product Code | HKS |
CFR Regulation Number | 886.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-05-28 |
Decision Date | 1986-07-11 |