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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 K013421
Device Name LIFEGUARD NASAL CPAP MASK AND ACCESSORIES
Applicant
Lifeguard Medical Products, Inc.
120 Elm Dr.
Plainfield,  IN  46168
Applicant Contact CRAIG JOHNSON
Correspondent
Lifeguard Medical Products, Inc.
120 Elm Dr.
Plainfield,  IN  46168
Correspondent Contact CRAIG JOHNSON
Regulation Number868.5905
Classification Product Code
BZD  
Date Received10/16/2001
Decision Date 01/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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