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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Positive Pressure Breathing, Intermittent
510(k) Number K905236
Device Name IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES
Applicant
Percussionaire Corp.
Bird Airlodge, Glengary Bay
P.O. Box 817
Sandpoint,  ID  83864
Applicant Contact FORREST M BIRD
Correspondent
Percussionaire Corp.
Bird Airlodge, Glengary Bay
P.O. Box 817
Sandpoint,  ID  83864
Correspondent Contact FORREST M BIRD
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received11/07/1990
Decision Date 04/18/1991
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
Recalls CDRH Recalls
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