Atlas FDA

COMBIDERM ACD

FDA 510(k) clearance K954918 · decided 1995-12-26

Clearance details

K-number
K954918
Device name
COMBIDERM ACD
Applicant
Convatec, A Bristol-Myers Squibb Co.
Decision
Substantially Equivalent
Date received
1995-10-26
Decision date
1995-12-26
Days to decision
61 days
Clearance type
Traditional
Product code
KMF
Device class
1
Regulation number
880.5090
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Princeton, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.