The following data is part of a premarket notification filed by Ocular Instruments, Inc. with the FDA for Disposable Vitrectomy Lens.
Device ID | K012096 |
510k Number | K012096 |
Device Name: | DISPOSABLE VITRECTOMY LENS |
Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
Applicant | OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
Contact | Raymond Graham |
Correspondent | Raymond Graham OCULAR INSTRUMENTS, INC. 2255 116TH AVE., N.E. Bellevue, WA 98004 -3039 |
Product Code | HJK |
CFR Regulation Number | 886.1385 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-07-05 |
Decision Date | 2001-08-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00630238118132 | K012096 | 000 |
00630238090001 | K012096 | 000 |
00630238090018 | K012096 | 000 |
00630238090025 | K012096 | 000 |
00630238090032 | K012096 | 000 |
00630238075206 | K012096 | 000 |
00630238075213 | K012096 | 000 |
00630238075220 | K012096 | 000 |
00630238075237 | K012096 | 000 |
00630238075244 | K012096 | 000 |
00630238117500 | K012096 | 000 |
00630238089982 | K012096 | 000 |