MARCO H AND TS-1 INSTRUMENT TABLES
FDA 510(k) clearance K930447 · decided 1993-07-06
Clearance details
- K-number
- K930447
- Device name
- MARCO H AND TS-1 INSTRUMENT TABLES
- 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
- HRJ
- Device class
- 1
- Regulation number
- 886.4855
- 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 |
|---|---|---|
| 910T MONTORIZED INSTRUMENT TABLE (K922242) | R.H. Burton Co. | 1992-09-30 |
| TBD, LENS MEASURING DEVICE (K912134) | Alcon Laboratories | 1991-07-25 |
| TECHNA VISION, INC.ELECTRIC TABLE (K853744) | Techna Vision | 1985-10-17 |
| RELIANCE 1379 (K853359) | Dentsply Intl. | 1985-09-24 |
| WOODLYN CLASSIC INSTRUMENT STAND (K841760) | Woodlyn, Inc. | 1984-06-19 |
| MACHEMER/TANO ROTATING (K833820) | Optical Micro Systems, Inc. | 1984-01-04 |
Recalls involving this device
No recalls on record reference this clearance.