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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 -1008
Applicant Contact LAWRENCE H WEISS
Correspondent
ZYGO INDUSTRIES, INC.
P.O. BOX 1008
PORTLAND,  OR  97207 -1008
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
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