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FDA 510(k) Application Details - K040817
Device Classification Name
Speculum, Vaginal, Nonmetal
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510(K) Number
K040817
Device Name
Speculum, Vaginal, Nonmetal
Applicant
ADVANCED UROLOGICAL DEVELOPMENTS
485 DARTMOUTH AVENUE
SAN CARLOS, CA 94070 US
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Contact
GERMAN BORODULIN
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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
03/30/2004
Decision Date
06/22/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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