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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Pulmonary Function Data
510(k) Number K001502
Device Name AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO
Applicant
Erich Jaeger GmbH
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Applicant Contact LARRY MURDOCK
Correspondent
Erich Jaeger GmbH
22705 Savi Ranch Pkwy.
Yorba Linda,  CA  92887 -4645
Correspondent Contact LARRY MURDOCK
Regulation Number868.1880
Classification Product Code
BZC  
Date Received05/15/2000
Decision Date 07/12/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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