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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K860838
Device Name INSPIRON DOUBLE SWIVEL TRACH ADAPTER
Applicant
INSPIRON CORP.
8600 ARCHIBALD AVE.
RANCHO CUCAMONGA,  CA  91730
Applicant Contact TERESITA AWIT
Correspondent
INSPIRON CORP.
8600 ARCHIBALD AVE.
RANCHO CUCAMONGA,  CA  91730
Correspondent Contact TERESITA AWIT
Regulation Number868.5810
Classification Product Code
BZA  
Date Received03/05/1986
Decision Date 04/09/1986
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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