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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851366
Device Name COMPANION 2800 VOLUME VENTILATOR
Applicant
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Applicant Contact HARTLEY C ERICSON
Correspondent
Puritan Bennett Corp.
9401 Indian Creek Pkwy.
P.O. Box 25905
Overland Park,  KS  66225
Correspondent Contact HARTLEY C ERICSON
Date Received04/05/1985
Decision Date 10/23/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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