FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION

K Number: K980147 · Decision Apr 13, 1998
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
119
Applicant Total
21
Review Days
88

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Basic Information

Device Name
YOUR CHOICE MULTI-PURPOSE CONTACT LENS CLEANING SOLUTION
K Number
K980147
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
886.5928
Medical Specialty
Ophthalmic
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Automatic Liquid Packaging, Inc.
Date Received
January 15, 1998
Decision Date
April 13, 1998
Product Code
LPN
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
LPN Accessories, Soft Lens Products

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Other Clearances by Automatic Liquid Packaging, Inc.

K Number Device Name
K994321 STERILE WATER AND 0.9% SODIUM CHLORIDE FOR IRRIGATION, USP
K000964 STERILE WATER OR O.9% SODIUM CHLORIDE, MODEL AL4100 & AL4109
K973829 IRRIGATION BOTTLE
K962079 HUMIDIFIER ADAPTER
K955104 HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER
K920306 OPTI-MOL FILTERED PUNCTURE PIN
K911770 OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
K901762 PREFILLED FLEXIBLE R.T. CONTAINERS W/STER. SODIUM
K901362 ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K901301 STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
Search all 21 clearances from Automatic Liquid Packaging, Inc. →