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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 K874679
Device Name TRACHEAL TUBE LASER SHIELD KIT
Applicant
AMERICAL CORP.
950FLANDERS RD.
POST OFFICE BOX 334
MYSTIC,  CT  06355
Applicant Contact RON J LUICH
Correspondent
AMERICAL CORP.
950FLANDERS RD.
POST OFFICE BOX 334
MYSTIC,  CT  06355
Correspondent Contact RON J LUICH
Regulation Number868.5730
Classification Product Code
BTR  
Date Received11/13/1987
Decision Date 04/11/1988
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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