Device Listing 1122653663

Listing Summary

Listing key
1122653663
Premarket submission
K160399
Device
Skyn Original Polyisoprene Lubricated Male Condom
Applicant
Ansell Healthcare Products, LLC
Product code
MOL
Decision date
2016-07-25

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
1484080406413002808272SURETEX, LTD.1N2026-01-0131/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai Amphur Phunphin Surat Thani TH 84130