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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, tubing and support, ventilator (w harness)
510(k) Number K792268
Device Name CIRCAPAK
Applicant
RESPIRATORY CARE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
RESPIRATORY CARE, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5975
Classification Product Code
BZO  
Date Received11/09/1979
Decision Date 11/27/1979
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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