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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Applicator, Ocular Pressure
510(k) Number K946194
Device Name WEE BAG O'MERCURY
Applicant
Microsurgical Technology, Inc.
723-B 9th Ave.
Kirkland,  WA  98033
Applicant Contact ISIDRO NILSSON
Correspondent
Microsurgical Technology, Inc.
723-B 9th Ave.
Kirkland,  WA  98033
Correspondent Contact ISIDRO NILSSON
Regulation Number886.4610
Classification Product Code
LCC  
Date Received12/20/1994
Decision Date 02/27/1995
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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