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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Communication, Powered
510(k) Number K924030
Device Name SCRIBE
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 Number890.3710
Classification Product Code
ILQ  
Date Received08/11/1992
Decision Date 03/04/1993
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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