Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K993390
Device Classification Name
Condom
More FDA Info for this Device
510(K) Number
K993390
Device Name
Condom
Applicant
REMED PHARMA
PO BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact
E.J. Smith
Other 510(k) Applications for this Contact
Regulation Number
884.5300
More FDA Info for this Regulation Number
Classification Product Code
HIS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/08/1999
Decision Date
02/14/2000
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact