SUSTAIN

Condom

HOLLENDER SUSTAINABLE BRANDS LLC

The following data is part of a premarket notification filed by Hollender Sustainable Brands Llc with the FDA for Sustain.

Pre-market Notification Details

• Device ID: K131866
• 510k Number: K131866
• Device Name: SUSTAIN
• Classification: Condom
• Applicant: HOLLENDER SUSTAINABLE BRANDS LLC 1468 HARWELL AVE Crofton, MD 21114
• Contact: E.j. Smith
• Correspondent: E.j. Smith; HOLLENDER SUSTAINABLE BRANDS LLC 1468 HARWELL AVE Crofton, MD 21114
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-06-24
• Decision Date: 2014-05-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20856078005393	K131866	000
00856078005382	K131866	000
20856078005058	K131866	000
00856078005047	K131866	000
20856078005034	K131866	000
20856078005027	K131866	000
00856078005016	K131866	000