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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K936110
Device Name ASPIRE
Applicant
DURA PHARMACEUTICALS, INC.
5880 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Applicant Contact KATHLEEN HEFFERNAN
Correspondent
DURA PHARMACEUTICALS, INC.
5880 PACIFIC CENTER BLVD.
SAN DIEGO,  CA  92121
Correspondent Contact KATHLEEN HEFFERNAN
Regulation Number868.1860
Classification Product Code
BZH  
Date Received12/23/1993
Decision Date 03/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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