POWERED EYE WASH
FDA 510(k) clearance K893829 · decided 1989-11-14
Clearance details
- K-number
- K893829
- Device name
- POWERED EYE WASH
- Applicant
- Sacks Model Makers
- Decision
- Substantially Equivalent
- Date received
- 1989-05-24
- Decision date
- 1989-11-14
- Days to decision
- 174 days
- Clearance type
- Traditional
- Product code
- MSI
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Ringwood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.