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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 K923816
Device Name CONTACT LENS CLEANING ACCESSORY
Applicant
Cramer Ent., Inc.
Two Paces W.
Suite 1780
Atlanta,  GA  30339
Applicant Contact THOMAS W CRAMER
Correspondent
Cramer Ent., Inc.
Two Paces W.
Suite 1780
Atlanta,  GA  30339
Correspondent Contact THOMAS W CRAMER
Regulation Number886.5928
Classification Product Code
LYL  
Date Received07/30/1992
Decision Date 03/08/1993
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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