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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 K881634
Device Name SIMPLICITY SERIES 5
Applicant
Quartet Technology, Inc.
52 Davis Rd.
Tyngsboro,  MA  01879
Applicant Contact STEVE MINER
Correspondent
Quartet Technology, Inc.
52 Davis Rd.
Tyngsboro,  MA  01879
Correspondent Contact STEVE MINER
Regulation Number890.3725
Classification Product Code
IQA  
Date Received04/14/1988
Decision Date 05/17/1988
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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