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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Oropharyngeal, Anesthesiology
510(k) Number K850248
Device Name DISPOSABLE GUEDEL 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 Number868.5110
Classification Product Code
CAE  
Date Received01/22/1985
Decision Date 03/12/1985
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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