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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 K853162
Device Name STERILE NASOPHARYNGEAL AIRWAY
Applicant
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Applicant Contact FLO BECKER
Correspondent
INMED CORP.
3030-B HOLCOMB BRIDGE RD.
NORCROSS,  GA  30071
Correspondent Contact FLO BECKER
Regulation Number868.5100
Classification Product Code
BTQ  
Date Received07/30/1985
Decision Date 08/06/1985
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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