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

LACRIMAL PLUG

K Number: K905750 · Decision Mar 14, 1991
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
3
Review Days
80

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Basic Information

Device Name
LACRIMAL PLUG
K Number
K905750
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Tamcenan Corp.
Date Received
December 24, 1990
Decision Date
March 14, 1991
Product Code
LZU
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
LZU Plug, Punctum

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Other Clearances by Tamcenan Corp.

K Number Device Name
K902308 TAMCENAN OCULAR EXPLANTS AND BANDS
K901618 OCULAR INFUSION CANNULA SYSTEM