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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K844467
Device Name OMS CRYO
Applicant
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Applicant Contact GERALD A CLAY
Correspondent
Optical Micro Systems, Inc.
8 Electronics Ave.
Danvers,  MA  01923
Correspondent Contact GERALD A CLAY
Date Received11/19/1984
Decision Date 02/22/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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