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FDA 510(k) Application Details - K991047
Device Classification Name
Condom With Nonoxynol-9
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510(K) Number
K991047
Device Name
Condom With Nonoxynol-9
Applicant
HARDCOVER PRODUCTS, INC.
55 ADMINISTRATION RD., UNIT 12
CONCORD, ONTARIO L4K 4G9 CA
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Contact
GERRY PERSON
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Regulation Number
884.5310
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Classification Product Code
LTZ
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More FDA Info for this Product Code
Date Received
03/30/1999
Decision Date
06/18/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OB - Obstetrics/Gynecology
Review Advisory Committee
OB - Obstetrics/Gynecology
Statement / Summary / Purged Status
Statement
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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