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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 K963131
Device Name GRASEBY ANDERSEN'S, INTEGRITY S700
Applicant
Graseby Andersen
500 Technology Ct.
Smyrna,  GA  30082
Applicant Contact JESS KASH
Correspondent
Graseby Andersen
500 Technology Ct.
Smyrna,  GA  30082
Correspondent Contact JESS KASH
Regulation Number868.1840
Classification Product Code
BZG  
Date Received08/12/1996
Decision Date 02/14/1997
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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