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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 K940793
Device Name DOUBLE TRACH SWIVEL CONNECTOR
Applicant
Seven Harvest Intl. Import & Export
P.O. Box 395
Tipton,  IN  46072
Applicant Contact CHARLES K MOUNTBATTEN-WINDSOR
Correspondent
Seven Harvest Intl. Import & Export
P.O. Box 395
Tipton,  IN  46072
Correspondent Contact CHARLES K MOUNTBATTEN-WINDSOR
Regulation Number868.5810
Classification Product Code
BZA  
Date Received02/22/1994
Decision Date 07/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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