Atlas FDA

SIALO DRAIN

FDA 510(k) clearance K072334 · decided 2008-07-18

Clearance details

K-number
K072334
Device name
SIALO DRAIN
Applicant
Sialo Technology, Ltd.
Decision
Substantially Equivalent
Date received
2007-08-20
Decision date
2008-07-18
Days to decision
333 days
Clearance type
Traditional
Product code
OAJ
Device class
1
Regulation number
878.4200
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Kfar Saba, IL
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.