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FDA 510(k) Application Details - K964181
Device Classification Name
Scale, Sponge, Surgical, Electrically-Powered
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510(K) Number
K964181
Device Name
Scale, Sponge, Surgical, Electrically-Powered
Applicant
SURGITRAC CORP.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact
JONATHAN S KAHAN
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Regulation Number
880.2740
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Classification Product Code
MRL
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More FDA Info for this Product Code
Date Received
10/18/1996
Decision Date
02/26/1997
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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