510(k) K905237
- Device
- EYE SEE INSTRUMENT
- Applicant
- KING TOOL, INC.
- 510(k) number
- K905237
- Product code
- HPN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-02-14
- Date received
- 1990-11-16
- Regulation
- 886.4445
- Classification name
- Magnet, Permanent
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CLARENCE A EMERSON
- Address
- 5350 Love Ln. Bozeman MT US 59718 59718
FDA Registration Numbers#
- 3014334038
- 9611112
- 8010704
- 3005809810
- 3005034064
- 1932402
- 1928237
- 1836161
- 8040278
- 8010099
- 3012185136
- 3003951061
- 9680515
- 3031231776
- 9611283
- 9680518
- 3003877407
- 3025303963
- 9611502
- 3004915686
- 3003244954
- 3003418325
- 1039131
- 9616245
- 8010343
- 1058726
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HPN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K896473 | H200 HANNA SUCTION TREPHINE SYSTEM FOR CORNEAL SUR | Emory University School of Medicine | 1990-02-09 |
| K880855 | PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG | Richard James, Inc. | 1988-04-01 |
| K860960 | RARE EARTH INTRA-OCULAR MAGNET | Ameritek, Inc. | 1986-03-31 |
| K831702 | RARE-EARTH INTRA-OCULAR MAGNET | Miami Eye Technology, Inc. | 1983-06-30 |
Legacy Summary#
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FDA Review#
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