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Synthetic Polyisoprene Lubricated Male Condom - 5 senses

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182438
510(k) Type
Abbreviated
Applicant
Sxwell Usa LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2018
Days to Decision
90 days
Submission Type
Summary

Synthetic Polyisoprene Lubricated Male Condom - 5 senses

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K182438
510(k) Type
Abbreviated
Applicant
Sxwell Usa LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/6/2018
Days to Decision
90 days
Submission Type
Summary