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FDA 510(k) Application Details - K052314
Device Classification Name
Speculum, Vaginal, Nonmetal
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510(K) Number
K052314
Device Name
Speculum, Vaginal, Nonmetal
Applicant
DYNAREX CORP.
10 GLENSHAW ST.
ORANGEBURG, NY 10962 US
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Contact
JAMES HURLMAN
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HIB
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More FDA Info for this Product Code
Date Received
08/25/2005
Decision Date
11/09/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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