MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
FDA 510(k) clearance K883575 · decided 1988-09-12
Clearance details
- K-number
- K883575
- Device name
- MODIFIED SITE MOBILE STAND FOR OPHTHALMIC USE
- Applicant
- Site Microsurgical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-22
- Decision date
- 1988-09-12
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- HMG
- Device class
- 1
- Regulation number
- 886.1860
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Horsham, PA, 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 |
|---|---|---|
| A-SCAN ROLL-AROUND STAND (K900161) | Jedmed Instrument Co. | 1990-02-16 |
| GORSK INSTRUMENT REST (K873554) | Gorsk, Inc. | 1987-10-23 |
| OPHTHALMIC TABLE (K841759) | Woodlyn, Inc. | 1984-06-01 |
Recalls involving this device
No recalls on record reference this clearance.