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SENSITIVE EYES(TM) SALINE SOLUTION (2ML) SIZE

FDA premarket approval P810039/S017 · decided 1993-05-28

Approval details

PMA number
P810039
Supplement
S017
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
SENSITIVE EYES(TM) SALINE SOLUTION (2ML) SIZE
Generic name
Accessories, soft lens products
Applicant
Bausch & Lomb, Inc.
Date received
1992-02-11
Decision date
1993-05-28
Days to decision
472 days
Decision code
APPR
Product code
LPN
Advisory committee
Ophthalmic
Expedited review
No
Location
Rochester, NY

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510(k) clearances by this applicant

RecordFirmDate
Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005)Bausch & Lomb, Inc.2019-10-04
Crystalsert Lens Delivery System (K173480)Bausch & Lomb, Inc.2017-12-11
Bausch + Lomb Injector System (K151102)Bausch & Lomb, Inc.2015-05-22
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208)Bausch & Lomb, Inc.2013-09-11
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575)Bausch & Lomb, Inc.2012-12-20
BAUSCH & LOMB IOL INJECTOR (K113852)Bausch & Lomb, Inc.2012-09-28
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909)Bausch & Lomb, Inc.2012-04-30
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877)Bausch & Lomb, Inc.2012-01-24