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FDA 510(k) Application Details - K010207
Device Classification Name
Automated External Defibrillators (Non-Wearable)
More FDA Info for this Device
510(K) Number
K010207
Device Name
Automated External Defibrillators (Non-Wearable)
Applicant
MEDICAL RESEARCH LABORATORIES, INC.
1000 ASBURY DR. NO.17
BUFFALO GROVE, IL 60089 US
Other 510(k) Applications for this Company
Contact
JOEL ORLINSKY
Other 510(k) Applications for this Contact
Regulation Number
870.5310
More FDA Info for this Regulation Number
Classification Product Code
MKJ
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More FDA Info for this Product Code
Date Received
01/23/2001
Decision Date
06/14/2001
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Special
Reviewed By Third Party
N
Expedited Review
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