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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Non-Continuous (Respirator)
510(k) Number K002001
Device Name BREEZE SLEEPGEAR WITH DREAMSEAL
Applicant
Puritan Bennett Corp.
2800 Northwest Blvd.
Minneapolis,  MN  55441
Applicant Contact DARIN BUSCH
Correspondent
Puritan Bennett Corp.
2800 Northwest Blvd.
Minneapolis,  MN  55441
Correspondent Contact DARIN BUSCH
Regulation Number868.5905
Classification Product Code
BZD  
Date Received06/30/2000
Decision Date 09/06/2000
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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