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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Environmental Control, Powered
510(k) Number K926029
Device Name INFRA-LINK
Applicant
Zygo Industries, Inc.
P.O. Box 1008
Portland,  OR  97207
Applicant Contact LAWRENCE H WEISS
Correspondent
Zygo Industries, Inc.
P.O. Box 1008
Portland,  OR  97207
Correspondent Contact LAWRENCE H WEISS
Regulation Number890.3725
Classification Product Code
IQA  
Date Received12/01/1992
Decision Date 03/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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