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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tube tracheostomy and tube cuff
510(k) Number K897102
Device Name HYDRASORB(TM)
Applicant
AVITAR, INC.
250 TURNPIKE ST.
CANTON,  MA  02021
Applicant Contact PAUL H PATRONE
Correspondent
AVITAR, INC.
250 TURNPIKE ST.
CANTON,  MA  02021
Correspondent Contact PAUL H PATRONE
Regulation Number868.5800
Classification Product Code
JOH  
Date Received12/21/1989
Decision Date 04/23/1990
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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