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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Nasopharyngeal
510(k) Number K940320
Device Name AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
Applicant
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Applicant Contact DAVID ANTHONY PUTZ
Correspondent
Ad-Tech Medical Instrument Corp
1901 William St.,
Racine,  WI  53404
Correspondent Contact DAVID ANTHONY PUTZ
Regulation Number868.5100
Classification Product Code
BTQ  
Date Received01/24/1994
Decision Date 09/19/1995
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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