Skyn Original Polyisoprene Lubricated Male Condom - Flavored

Condom, Synthetic

Ansell Healthcare Products LLC.

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.

Pre-market Notification Details

• 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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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