510(k) K912268
- Device
- LANDERS NOTCHED VITRECTOMY LENS RING
- Applicant
- OCULAR INSTRUMENTS, INC.
- 510(k) number
- K912268
- Product code
- HNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-07
- Date received
- 1991-05-22
- Regulation
- 886.4350
- Classification name
- Ring, Ophthalmic (flieringa)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- TAMSIN J ERICKSON
- Address
- 2255 116th Ave., NE Bellevue WA US 98004 98004
FDA Registration Numbers#
- 3017857440
- 9616250
- 3007583964
- 3011137372
- 9616972
- 3002224346
- 3009027787
- 3005548740
- 3007589150
- 8021817
- 3009513193
- 2248180
- 1058726
- 8040382
- 3003039352
- 9615659
- 1417592
- 3023657851
- 3008754084
- 1720747
- 3004571672
- 3029990829
- 3006380247
- 2953726
- 9611283
- 1045379
- 3013503739
- 3004215117
- 3010041511
- 8040278
- 3010383847
- 9710098
- 3004475955
- 3006017180
- 9612075
- 1836161
- 1923569
- 2242450
- 9617458
- 2916714
- 3006677911
- 3012833022
- 3013576617
- 1646747
- 3009504366
- 1528142
- 1421879
- 2031962
- 1932180
- 3008342610
- 1421101
- 8040381
- 3006550126
- 9680718
- 3003418325
- 8010372
- 3015177648
- 2529392
- 9614107
- 3031231776
- 8010694
- 1313525
- 2521877
- 3010687973
- 3011110913
- 1056350
- 3003244954
- 1935627
- 3003553186
- 8043467
- 9611502
- 3012185136
- 3006554912
- 3007334784
- 3003951061
- 2029275
- 3014865
- 9617768
- 2529846
- 3019924
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912269 | LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING | Ocular Instruments, Inc. | 1991-08-07 |
| K912151 | LANDERS THREE STRUT VITRECTOMY LENS RING | Ocular Instruments, Inc. | 1991-07-25 |
| K902496 | LANDERS VITRECTOMY LENS RING W/INFUSION | Ocular Instruments, Inc. | 1990-07-24 |
| K863775 | RK VACUUM FIXATION RING SYSTEM | Ameritek, Inc. | 1986-10-20 |
| K850991 | LANDERS VITRECTOMY LENS RING SYSTEMS | Ocular Instruments, Inc. | 1985-03-29 |
| K832912 | GELENDER VACUUM FIXATION RING SYS | Miami Eye Technology, Inc. | 1984-01-10 |
Legacy Summary#
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FDA Review#
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