The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Landers Vitrectomy Lens Ring W/infusion.
Device ID | K902496 |
510k Number | K902496 |
Device Name: | LANDERS VITRECTOMY LENS RING W/INFUSION |
Classification | Ring, Ophthalmic (flieringa) |
Applicant | OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
Contact | J Erickson |
Correspondent | J Erickson OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
Product Code | HNH |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-05 |
Decision Date | 1990-07-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630238007894 | K902496 | 000 |