Last synced on 30 September 2022 at 11:05 pm

KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081886
510(k) Type
Abbreviated
Applicant
KAREX INDUSTRIES SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
2/6/2009
Days to Decision
219 days
Submission Type
Summary

KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K081886
510(k) Type
Abbreviated
Applicant
KAREX INDUSTRIES SDN BHD
Country
Malaysia
FDA Decision
Substantially Equivalent
Decision Date
2/6/2009
Days to Decision
219 days
Submission Type
Summary