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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 K910463
Device Name MEROCEL(R) LASER-GUARD(TM)
Applicant
MEROCEL CORP.
950 FLANDERS RD.
MYSTIC,  CT  06355 -0334
Applicant Contact DOM L GATTO
Correspondent
MEROCEL CORP.
950 FLANDERS RD.
MYSTIC,  CT  06355 -0334
Correspondent Contact DOM L GATTO
Regulation Number868.5730
Classification Product Code
BTR  
Date Received01/25/1991
Decision Date 04/06/1992
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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