FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

CONTACT LENSES

K Number: K934859 · Decision Dec 21, 1993
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
12
Applicant Total
2
Review Days
70

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Basic Information

Device Name
CONTACT LENSES
K Number
K934859
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
886.1405
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Arno Intl., Inc.
Date Received
October 12, 1993
Decision Date
December 21, 1993
Product Code
HPC
Advisory Committee
Ophthalmic
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
HPC Set, Lens, Trial, Ophthalmic

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Other Clearances by Arno Intl., Inc.

K Number Device Name
K934858 FRAME SPECTACLE