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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Spectacle, Non-Custom (Prescription)
510(k) Number K874681
Device Name SWIRL - A PRE-MOISTENED CLEANING TISSUE FOR EYES
Applicant
Klockner Contract Packaging, Inc.
5300 Klockner Dr.
P.O. Box 38100
Richmond,  VA  23231
Applicant Contact G BACON,RPH
Correspondent
Klockner Contract Packaging, Inc.
5300 Klockner Dr.
P.O. Box 38100
Richmond,  VA  23231
Correspondent Contact G BACON,RPH
Regulation Number886.5844
Classification Product Code
HQG  
Date Received11/13/1987
Decision Date 02/05/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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