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FDA 510(k) Application Details - K003380
Device Classification Name
Dilator, Vaginal
More FDA Info for this Device
510(K) Number
K003380
Device Name
Dilator, Vaginal
Applicant
BIOTEQUE AMERICA, INC.
340 EAST MAPLE AVE., #204-C
LANGHORNE, PA 19047 US
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Contact
DENIS DORSEY
Other 510(k) Applications for this Contact
Regulation Number
884.3900
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Classification Product Code
HDX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/31/2000
Decision Date
01/29/2001
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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