MARCO TRIAL SETS
FDA 510(k) clearance K930446 · decided 1993-07-06
Clearance details
- K-number
- K930446
- Device name
- MARCO TRIAL SETS
- Applicant
- Marco Ophthalmic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-26
- Decision date
- 1993-07-06
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- HPC
- Device class
- 1
- Regulation number
- 886.1405
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Jacksonville, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BOBES LENS SET (K945443) | Bobes S.A. | 1995-07-19 |
| OTI MODEL TLS-60 (K951437) | Oti Medical, LLC | 1995-04-11 |
| OPHTHALMIC TRIAL LENSES (K930195) | Optimark Accessories and Instruments | 1994-01-06 |
| CONTACT LENSES (K934859) | Arno Intl., Inc. | 1993-12-21 |
| BURTON TRIAL LENS SET (K924786) | R.H. Burton Co. | 1993-04-14 |
| TRIAL LENS SET (K920571) | R.H. Burton Co. | 1992-05-07 |
| WOODLYN FULL APERTURE TRIAL LENS SET (K900478) | Woodlyn, Inc. | 1990-02-21 |
| CONFIRMATION TESTS (K873907) | Richmond Products, Inc. | 1987-12-29 |
| ACC CROSS CYLINDERS (K852056) | Ascon Medical Instruments, Ltd. | 1985-06-05 |
| TRIA LENS SET (K843095) | Optek Medico Co., Ltd. | 1984-10-05 |
| WOODLYN CLASSIC TRIAL LENS SET (K841766) | Woodlyn, Inc. | 1984-06-01 |
| LENS SET, MENTOR TRIAL (K770389) | Codman & Shurtleff, Inc. | 1977-03-14 |
Recalls involving this device
No recalls on record reference this clearance.