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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 K951718
Device Name HM-SPIRO
Applicant
Hill-Med, Inc.
C/O Regulatory/Market Service
P.O. Box 2010
Palm Harbor,  FL  34682
Applicant Contact ERNESTO ACKERMAN
Correspondent
Hill-Med, Inc.
C/O Regulatory/Market Service
P.O. Box 2010
Palm Harbor,  FL  34682
Correspondent Contact ERNESTO ACKERMAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/13/1995
Decision Date 12/20/1995
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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