Atlas FDA

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.