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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spirometer, Diagnostic
510(k) Number K920877
Device Name THE KEYSTONE SYSTEM
Applicant
S & M Instrument Co.
202 Airport Blvd.
Doylestown,  PA  18901
Applicant Contact WILLIAM LETVENKO
Correspondent
S & M Instrument Co.
202 Airport Blvd.
Doylestown,  PA  18901
Correspondent Contact WILLIAM LETVENKO
Regulation Number868.1840
Classification Product Code
BZG  
Date Received02/26/1992
Decision Date 12/23/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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