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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accessories, solution, ultrasonic cleaners for lenses
510(k) Number K021699
Device Name AUTOLENS CLEANING AND DISINFECTING UNIT
Applicant
AUTOLENS INC.
17003 HORN POINT DR.
GAITHERSBURG,  MD  20878
Applicant Contact RICHARD E LIPPMAN
Correspondent
AUTOLENS INC.
17003 HORN POINT DR.
GAITHERSBURG,  MD  20878
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5928
Classification Product Code
LYL  
Subsequent Product Code
LPN  
Date Received05/22/2002
Decision Date 12/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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