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FDA 510(k) Application Details - K946349
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
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510(K) Number
K946349
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
SPECS USA, INC.
2 NORTH TAMIAMI TRAIL, #312
SARASOTA, FL 34236 US
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Contact
BOB HANDREN
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Regulation Number
892.1560
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Classification Product Code
IYO
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More FDA Info for this Product Code
Date Received
12/30/1994
Decision Date
05/24/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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