FDA 510(k) Application Details - K960907

Device Classification Name

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510(K) Number K960907
Device Name ORCA
Applicant LUNAR CORP.
313 WEST BELTLINE HIGHWAY
MADISON, WI 53713 US
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Contact Gary Syring
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Regulation Number

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Classification Product Code OXO
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Date Received 03/05/1996
Decision Date 05/20/1996
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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