MICROTRAK EIA AUTOWASHER
FDA 510(k) clearance K891269 · decided 1989-05-01
Clearance details
- K-number
- K891269
- Device name
- MICROTRAK EIA AUTOWASHER
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-09
- Decision date
- 1989-05-01
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- JYC
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Palo Alto, CA, 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 |
|---|---|---|
| HOUSE SUCTION IRRIGATOR (K780153) | Edward Weck, Inc. | 1978-02-02 |
Recalls involving this device
No recalls on record reference this clearance.