Atlas FDA

LIPOCONTROL

FDA 510(k) clearance K090754 · decided 2011-01-21

Clearance details

K-number
K090754
Device name
LIPOCONTROL
Applicant
Osyris Medical
Decision
Substantially Equivalent
Date received
2009-03-20
Decision date
2011-01-21
Days to decision
672 days
Clearance type
Traditional
Product code
ORK
Device class
2
Regulation number
878.4810
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
France, FR
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.