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

TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT

K Number: K890919 · Decision May 16, 1989
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
7
Review Days
82

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Basic Information

Device Name
TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K Number
K890919
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Eagle Vision, Inc.
Date Received
February 23, 1989
Decision Date
May 16, 1989
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 Eagle Vision, Inc.

K Number Device Name
K053333 EAGLEVISION GELLANSERTS, MODEL REF 0040
K030353 MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K991130 FLEXPLUG
K905427 EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
K890920 EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
K883233 EV MONOCANALICULAR STENT (TM)