510(k) K890992
- Device
- WOODLYN OPHTHALMIC PROJECTOR
- Applicant
- Woodlyn, Inc.
- 510(k) number
- K890992
- Product code
- HOS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-17
- Date received
- 1989-02-27
- Regulation
- 886.1680
- Classification name
- Projector, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD NIELSEN
- Address
- 2920 Malmo Dr. Arlington Heights IL US 60005 60005
FDA Registration Numbers#
- 3004784203
- 2242863
- 3003851947
- 3008197763
- 3013436538
- 9612297
- 3004095901
- 3005771344
- 9710516
- 3005785090
- 3010455030
- 3005301392
- 3011898560
- 2031962
- 3007343325
- 3003984265
- 2939653
- 3011659880
- 3015972897
- 3008729548
- 3011110913
- 9614661
- 3002808383
- 3004167900
- 3007817024
- 3013576617
- 3003553186
- 3009515444
- 8020986
- 3013148497
- 9616199
- 3009132348
- 3008044461
- 3033566
- 3004441848
- 3010363281
- 3003951061
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HOS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K936200 | WIRELESS CHART PROJECTOR,HCP-W 721 | Canon USA, Inc. | 1994-09-28 |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Marco Ophthalmic, Inc. | 1993-07-06 |
| K924784 | BURTON PROJECTOR HEAD - MODEL 6000-H | R.H. Burton Co. | 1993-04-05 |
| K921214 | OPHTHALMIC PROJECTOR | Luneau Ophtalmologie SA | 1992-06-11 |
| K862519 | BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR | Bausch & Lomb, Inc. | 1986-07-23 |
| K812706 | MILLER/NADLER GLARE TESTER | Mosebach Electric & Supply | 1981-11-16 |
| K811180 | ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ | American Optical Corp. | 1981-05-15 |
| K781658 | PROJECTOR, ACCU-CHART ACUITY | Bausch & Lomb, Inc. | 1978-10-17 |