Atlas FDA

STERICON SALINE SOLUTION

FDA premarket approval P850070/S002 · decided 1987-12-29

Approval details

PMA number
P850070
Supplement
S002
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
STERICON SALINE SOLUTION
Generic name
Accessories, soft lens products
Applicant
Automatic Liquid Packaging, Inc.
Date received
1987-06-17
Decision date
1987-12-29
Days to decision
195 days
Decision code
APPR
Product code
LPN
Advisory committee
Ophthalmic
Expedited review
No
Location
Woodstock, IL

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510(k) clearances by this applicant

RecordFirmDate
STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP (K994321)Automatic Liquid Packaging, Inc.2000-10-25
STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109 (K000964)Automatic Liquid Packaging, Inc.2000-04-25
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION (K980147)Automatic Liquid Packaging, Inc.1998-04-13
IRRIGATION BOTTLE (K973829)Automatic Liquid Packaging, Inc.1998-02-23
HUMIDIFIER ADAPTER (K962079)Automatic Liquid Packaging, Inc.1996-07-31
HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER (K955104)Automatic Liquid Packaging, Inc.1996-06-11
OPTI-MOL FILTERED PUNCTURE PIN (K920306)Automatic Liquid Packaging, Inc.1992-04-06
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM (K911770)Automatic Liquid Packaging, Inc.1991-10-15