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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tent, Oxygen
510(k) Number K851666
Device Name MEDI-COMP NEONATAL OXYGEN HOOD
Applicant
Medicomp, Inc.
411 Freemont St.
Anoka,  MN  55303
Applicant Contact DUNCAN C JOHNSON
Correspondent
Medicomp, Inc.
411 Freemont St.
Anoka,  MN  55303
Correspondent Contact DUNCAN C JOHNSON
Regulation Number868.5700
Classification Product Code
BYL  
Date Received04/23/1985
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
Predetermined Change
Control Plan Authorized		 No
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