FDA 510(k) Application Details - K981267

Device Classification Name Collimator, Manual, Radiographic

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510(K) Number K981267
Device Name Collimator, Manual, Radiographic
Applicant DYNARAD CORP.
19 JEFRYN BLVD. WEST
DEER PARK, NY 11729 US
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Contact RAYMOND MANEZ
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Regulation Number 892.1610

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Classification Product Code IZX
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Date Received 04/07/1998
Decision Date 05/06/1998
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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