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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K883096
Device Name TRACHEAL TUBE LASER SHIELD KIT
Applicant
Americal Corp.
950flanders Rd.
Post Office Box 334
Mystic,  CT  06355
Applicant Contact RON CERCONE
Correspondent
Americal Corp.
950flanders Rd.
Post Office Box 334
Mystic,  CT  06355
Correspondent Contact RON CERCONE
Regulation Number868.5730
Classification Product Code
BTR  
Date Received07/22/1988
Decision Date 09/08/1988
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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