Atlas FDA

ALBA HEALTH CARE IODOFORM PACKING STRIP

FDA 510(k) clearance K864689 · decided 1987-01-20

Clearance details

K-number
K864689
Device name
ALBA HEALTH CARE IODOFORM PACKING STRIP
Applicant
Alba Health Care
Decision
Substantially Equivalent
Date received
1986-12-02
Decision date
1987-01-20
Days to decision
49 days
Clearance type
Traditional
Advisory committee
Unknown
Location
Valdese, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.