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FDA 510(k) Application Details - K120898
Device Classification Name
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510(K) Number
K120898
Device Name
KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
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Contact
RON HASELHORST
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Regulation Number
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Classification Product Code
OTJ
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Date Received
03/26/2012
Decision Date
08/03/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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