The following data is part of a premarket notification filed by Ansell Healthcare Products Llc. with the FDA for Skyn Original Polyisoprene Lubricated Male Condom - Flavored.
Device ID | K171172 |
510k Number | K171172 |
Device Name: | Skyn Original Polyisoprene Lubricated Male Condom - Flavored |
Classification | Condom, Synthetic |
Applicant | Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
Contact | Robert Mahler |
Correspondent | Robert Mahler Ansell Healthcare Products LLC. 111 Wood Avenue South, Suite 210 Iselin, NJ 08830 |
Product Code | MOL |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-04-21 |
Decision Date | 2017-08-02 |
Summary: | summary |