The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Schirmer Nylon Suture Laser Lens.
Device ID | K871099 |
510k Number | K871099 |
Device Name: | SCHIRMER NYLON SUTURE LASER LENS |
Classification | Lens, Surgical, Laser, Accesssory, Ophthalmic Laser |
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 | LQJ |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-19 |
Decision Date | 1987-04-27 |