Atlas FDA

KLEENIT BY QMED

FDA 510(k) clearance K843559 · decided 1984-10-24

Clearance details

K-number
K843559
Device name
KLEENIT BY QMED
Applicant
Qmed, Inc.
Decision
Substantially Equivalent
Date received
1984-09-10
Decision date
1984-10-24
Days to decision
44 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Louisville, KY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.