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510(k) K904273

Device
MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB.
Applicant
CARTER PRODUCTS
510(k) number
K904273
Product code
LTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1990-10-31
Date received
1990-09-17
Regulation
884.5310
Classification name
Condom With Nonoxynol-9
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN KOLAKOWSKY
Address
Half Acre Rd. Cranbury NJ US 08512 08512

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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