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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 K062224
Device Name RESPCARE HYBRID AV MASK
Applicant
Respcare, Inc.
6601 Lyons Rd., Suites B1-B4
Coconut Creek,  FL  33073
Applicant Contact FRANK PELC
Correspondent
Respcare, Inc.
6601 Lyons Rd., Suites B1-B4
Coconut Creek,  FL  33073
Correspondent Contact FRANK PELC
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/02/2006
Decision Date 08/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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