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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape, Measuring, Rulers And Calipers
510(k) Number K880441
Device Name PEDIATRIC AIRWAY MEASUREMENT SYSTEM & P.A.M.S.
Applicant
Plane Iii, Inc.
P.O. Box 940
Lebanon,  NH  03766
Applicant Contact ALLEN J HINKLE
Correspondent
Plane Iii, Inc.
P.O. Box 940
Lebanon,  NH  03766
Correspondent Contact ALLEN J HINKLE
Regulation Number878.4800
Classification Product Code
FTY  
Date Received02/02/1988
Decision Date 02/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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