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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name hood, oxygen, infant
510(k) Number K962182
Device Name BURLEW INFANT HOOD
Applicant
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Applicant Contact PAUL E DRYDEN
Correspondent
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Correspondent Contact PAUL E DRYDEN
Regulation Number868.5700
Classification Product Code
FOG  
Date Received06/06/1996
Decision Date 07/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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