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FDA 510(k) Application Details - K072762
Device Classification Name
Speculum, Vaginal, Nonmetal
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510(K) Number
K072762
Device Name
Speculum, Vaginal, Nonmetal
Applicant
DEPALT INC.
5013 STONEWICK COURT
PLANO, TX 75093 US
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RAJEEV PATEL
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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
09/28/2007
Decision Date
01/22/2008
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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