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FDA 510(k) Application Details - K971473
Device Classification Name
Brush, Scrub, Operating-Room
More FDA Info for this Device
510(K) Number
K971473
Device Name
Brush, Scrub, Operating-Room
Applicant
M-PACT WORLDWIDE MANAGEMENT CORP.
1040 O.C.L. PKWY.
INTECH BUSINESS PK.
EUDORA, KS 66025 US
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Contact
BARRY HALE
Other 510(k) Applications for this Contact
Regulation Number
878.4800
More FDA Info for this Regulation Number
Classification Product Code
GEC
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More FDA Info for this Product Code
Date Received
04/23/1997
Decision Date
07/07/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K971473
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