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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 K770927
Device Name PART NO. 66-00311
Applicant
Harlake Cyprane
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Harlake Cyprane
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.1840
Classification Product Code
BZG  
Date Received05/20/1977
Decision Date 05/26/1977
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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