CHARTER HARD CONTACT LENS CLEANING SOLUTION

Lens, Contact (polymethylmethacrylate)

PACO PHARMACEUTICAL SERVICES, INC.

The following data is part of a premarket notification filed by Paco Pharmaceutical Services, Inc. with the FDA for Charter Hard Contact Lens Cleaning Solution.

Pre-market Notification Details

Device IDK865111
510k NumberK865111
Device Name:CHARTER HARD CONTACT LENS CLEANING SOLUTION
ClassificationLens, Contact (polymethylmethacrylate)
Applicant PACO PHARMACEUTICAL SERVICES, INC. 1200 PACO WAY BUILDING 19 Lakewood,  NJ  08701
ContactJoanne B Marriott
CorrespondentJoanne B Marriott
PACO PHARMACEUTICAL SERVICES, INC. 1200 PACO WAY BUILDING 19 Lakewood,  NJ  08701
Product CodeHPX  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-31
Decision Date1987-01-20

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