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FDA 510(k) Application Details - K983716
Device Classification Name
Speculum, Vaginal, Nonmetal
More FDA Info for this Device
510(K) Number
K983716
Device Name
Speculum, Vaginal, Nonmetal
Applicant
VITALCARE GROUP, INC.
15800 N.W. 13TH AVE.
MIAMI, FL 33169 US
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Contact
GINGER TALLEY
Other 510(k) Applications for this Contact
Regulation Number
884.4530
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Classification Product Code
HIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/1998
Decision Date
12/23/1998
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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