FDA 510(k) Application Details - K971473

Device Classification Name Brush, Scrub, Operating-Room

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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
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Regulation Number 878.4800

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Classification Product Code GEC
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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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