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

CONCENTRATED CLEANER FOR HARD CONTACTS

K Number: K820818 · Decision Apr 9, 1982
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
73
Applicant Total
92
Review Days
16

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Basic Information

Device Name
CONCENTRATED CLEANER FOR HARD CONTACTS
K Number
K820818
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Applicant
Bausch & Lomb, Inc.
Date Received
March 24, 1982
Decision Date
April 9, 1982
Product Code
HPX
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
HPX Lens, Contact (Polymethylmethacrylate)

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K122575 BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
K113852 BAUSCH & LOMB IOL INJECTOR
K112909 OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION
K111877 EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
K112192 NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
K101325 STELLARIS PC VISION ENHANCEMENT SYSTEM
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