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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 K965042
Device Name MICRODL DIARYCARD SPIROMETER
Applicant
MICRO DIRECT, INC.
840 POWNAL RD.
AUBURN,  ME  04210
Applicant Contact DAVID R STASZAK
Correspondent
MICRO DIRECT, INC.
840 POWNAL RD.
AUBURN,  ME  04210
Correspondent Contact DAVID R STASZAK
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/17/1996
Decision Date 06/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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