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510(k) K001978

Device
'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9
Applicant
THAI NIPPON RUBBER INDUSTRY CO., LTD.
510(k) number
K001978
Product code
LTZ  
Decision
Substantially Equivalent (SESE)
Decision date
2000-08-08
Date received
2000-06-29
Regulation
884.5310
Classification name
Condom With Nonoxynol-9
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ELI J CARTER
Address
1219 Little Creek Rd. Durham NC US 27713 27713

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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