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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Powered (Resuscitator)
510(k) Number K882833
Device Name THE BERG RESUSCITATION APPARATUS
Applicant
HURSCH ENT., INC.
2435 E. NORTH STREET, SUITE
295
GREENVILLE,  SC  29615
Applicant Contact KENT A BERG
Correspondent
HURSCH ENT., INC.
2435 E. NORTH STREET, SUITE
295
GREENVILLE,  SC  29615
Correspondent Contact KENT A BERG
Regulation Number868.5925
Classification Product Code
BTL  
Date Received07/08/1988
Decision Date 08/19/1988
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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