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FDA 510(k) Application Details - K022502
Device Classification Name
Injector, Fluid, Non-Electrically Powered
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510(K) Number
K022502
Device Name
Injector, Fluid, Non-Electrically Powered
Applicant
EQUIDYNE SYSTEMS, INC.
11770 BERNARDO PLAZA CT.
SUITE 351
SAN DIEGO, CA 92128 US
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Contact
JIM BARELY
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Regulation Number
880.5430
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Classification Product Code
KZE
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More FDA Info for this Product Code
Date Received
07/29/2002
Decision Date
09/05/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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