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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K905235
Device Name VDR SINUSOIDAL PERCUSIONATOR FAMILY/RELATE ACCESS
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 Number868.5895
Classification Product Code
CBK  
Date Received11/07/1990
Decision Date 05/03/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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