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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Orthodontic
510(k) Number K911399
Device Name NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)
Applicant
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Applicant Contact KENNETH B HERLAND
Correspondent
Aequitron Medical, Inc.
14800 28th Ave. N.
Plymouth,  MN  55447
Correspondent Contact KENNETH B HERLAND
Regulation Number872.5410
Classification Product Code
DZD  
Date Received03/29/1991
Decision Date 09/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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