FDA 510(k) Application Details - K961331

Device Classification Name Ventilator, Emergency, Manual (Resuscitator)

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510(K) Number K961331
Device Name Ventilator, Emergency, Manual (Resuscitator)
Applicant MEDICAL MARKETING CONCEPTS
2310 YORK RD.
ROANOKE, VA 24015 US
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Contact BOB MARTIN
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Regulation Number 868.5915

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Classification Product Code BTM
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Date Received 04/08/1996
Decision Date 06/28/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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