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FDA 510(k) Application Details - K983393
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K983393
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
PHYSIO-CONTROL CORP.
11811 WILLOWS RD. N.E.
P.O. BOX 97006
REDMOND, WA 98073-9706 US
Other 510(k) Applications for this Company
Contact
SHERRI L POCOCK
Other 510(k) Applications for this Contact
Regulation Number
870.5310
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Classification Product Code
MKJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/1998
Decision Date
05/05/1999
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
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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