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FDA 510(k) Application Details - K984218
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K984218
Device Name
Condom
Applicant
GLIMEX CORP.
705-2 EAST BIDWELL ST., #131
FOLSOM, CA 95630 US
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Contact
JEFF HACKETT
Other 510(k) Applications for this Contact
Regulation Number
884.5300
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Classification Product Code
HIS
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More FDA Info for this Product Code
Date Received
11/24/1998
Decision Date
12/17/1998
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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