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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
Predetermined Change
Control Plan Authorized		 No
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