FDA 510(k) Application Details - K853732

Device Classification Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

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510(K) Number K853732
Device Name Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Applicant PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND, WA US
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Contact MICHAEL B GROPP
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Regulation Number 870.5550

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Classification Product Code DRO
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Date Received 09/06/1985
Decision Date 12/09/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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