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FDA 510(k) Application Details - K971979
Device Classification Name
Speculum, Vaginal, Nonmetal
More FDA Info for this Device
510(K) Number
K971979
Device Name
Speculum, Vaginal, Nonmetal
Applicant
PLAYTEX PRODUCTS, INC.
215 COLLEGE RD.
P.O. BOX 728
PARAMUS, NJ 07652 US
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Contact
MARK E ROSENGARTEN
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
05/29/1997
Decision Date
09/26/1997
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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