510(k) K871130
- Device
- Contact Lens Tweezers
- Applicant
- S. M. C. MEDI-TECH CORP.
- 510(k) number
- K871130
- Product code
- KYE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-12
- Date received
- 1987-03-20
- Regulation
- 886.5420
- Classification name
- Inserter/Remover Contact Lens
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LAU
- Address
- 1931 N. Great Southwest Pkwy. Grand Prairie TX US 75050 75050
FDA Registration Numbers#
- 3015427564
- 1523955
- 1315522
- 3011919098
- 2518410
- 1000375210
- 3041506752
- 3038910345
- 3007137643
- 3026961547
- 1722370
- 8022166
- 2085143
- 3010676356
- 3006633372
- 8040278
- 1937310
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KYE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872567 | SOFT CONTACT LENS REMOVER | Magnivision, Inc. | 1987-08-10 |
| K872591 | HARD CONTACT LENS REMOVER. ITEM #289 | Magnivision, Inc. | 1987-08-04 |
| K870072 | SUMMIT OPTICS CONTACT LENS REMOVER | Dayton Mfg. Co. | 1987-02-12 |
| K850983 | MARLIN SOFT LENS TWEEZER | Marlin Industries | 1985-09-10 |
| K850984 | MARLIN SOFT LENS HANDLER | Marlin Industries | 1985-09-10 |
| K830738 | LENSERT CONTACT LENS CLEANING & INSERT | Jermyn Specialties of California | 1983-06-10 |
| K830496 | DMV ANGLER | Dmv Contact Lens Co. | 1983-03-09 |
| K782140 | REMOVER, SOFT-SERT CONTACT LENS | Mcmurray and Pendergost | 1979-02-12 |
| K780931 | SOFT LENS INSERTER | Soft-Sert | 1978-06-28 |
| K780663 | CONTACT LENS REMOVER AND INSERTER | Dmv Contact Lens Co. | 1978-05-17 |
| K780664 | SOFT LENS REMOVER/INSERTER/MANIPULATOR | Dmv Contact Lens Co. | 1978-05-17 |