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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name compressor, air, portable
510(k) Number K946039
Device Name MODEL #5000 PULMO PLUS
Applicant
INTERNATIONAL MEDICAL SYSTEMS
P.O. BOX 66007
WEST DES MOLNES,  IA  50265
Applicant Contact MARK D HEBENSTREIT
Correspondent
INTERNATIONAL MEDICAL SYSTEMS
P.O. BOX 66007
WEST DES MOLNES,  IA  50265
Correspondent Contact MARK D HEBENSTREIT
Regulation Number868.6250
Classification Product Code
BTI  
Date Received12/12/1994
Decision Date 06/16/1995
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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