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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 K052227
Device Name RESPCARE FACE MASK
Applicant
RESPCARE INC.
6601 LYONS ROAD, SUITES B1-B4
COCONUT CREEK,  FL  33073
Applicant Contact FRANK PELC
Correspondent
RESPCARE INC.
6601 LYONS ROAD, SUITES B1-B4
COCONUT CREEK,  FL  33073
Correspondent Contact FRANK PELC
Regulation Number868.5905
Classification Product Code
BZD  
Date Received08/16/2005
Decision Date 10/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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