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

MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS

K Number: K030353 · Decision Apr 25, 2003
Classifications
1
FEI Numbers
20
Registration Numbers
21
Same Product Code
30
Applicant Total
7
Review Days
81

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS
K Number
K030353
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Eagle Vision, Inc.
Date Received
February 3, 2003
Decision Date
April 25, 2003
Product Code
OKS
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
OKS Lacrimal Stents And Intubation Sets

Similar 510(k) Clearances

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

View all

Other Clearances by Eagle Vision, Inc.

K Number Device Name
K053333 EAGLEVISION GELLANSERTS, MODEL REF 0040
K991130 FLEXPLUG
K905427 EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
K890919 TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K890920 EAGLE VISION-FREEMAN(TM) PUNCTAL VALVE
K883233 EV MONOCANALICULAR STENT (TM)