FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

EUSOL-C

K Number: K063617 · Decision Feb 8, 2007
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
20
Applicant Total
2
Review Days
65

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Basic Information

Device Name
EUSOL-C
K Number
K063617
Device Class
FDA unclassified
Clearance Type
Special
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Al.Chi.Mi.A
Date Received
December 5, 2006
Decision Date
February 8, 2007
Product Code
LYX
Advisory Committee
Unknown
Review Advisory Committee
OP
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LYX Media, Corneal Storage

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (LYX), ordered by most recent decision date.

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Other Clearances by Al.Chi.Mi.A

K Number Device Name
K032422 EUSOL-C