FDA 510(k) Application Details - K972136

Device Classification Name System, X-Ray, Angiographic

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510(K) Number K972136
Device Name System, X-Ray, Angiographic
Applicant PERKINS MFG. CO.
1510 NORTH WASHINGTON AVE.
DALLAS, TX 75204 US
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Contact JIM FURSE
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Regulation Number 892.1600

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Classification Product Code IZI
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Date Received 06/06/1997
Decision Date 06/26/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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