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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 K873949
Device Name RORERTAZZI NASOPHARYNGEAL AIRWAY
Applicant
Penn Medical Devices, Inc.
12 Ridge St.
Basking Ridge,  NJ  07920
Applicant Contact CHARLES E MEISCH
Correspondent
Penn Medical Devices, Inc.
12 Ridge St.
Basking Ridge,  NJ  07920
Correspondent Contact CHARLES E MEISCH
Regulation Number868.5100
Classification Product Code
BTQ  
Date Received09/28/1987
Decision Date 10/20/1987
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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