One Touch

Condom

Thai Nippon Rubber Industry Public Company Ltd

The following data is part of a premarket notification filed by Thai Nippon Rubber Industry Public Company Ltd with the FDA for One Touch.

Pre-market Notification Details

• Device ID: K181844
• 510k Number: K181844
• Device Name: One Touch
• Classification: Condom
• Applicant: Thai Nippon Rubber Industry Public Company Ltd 1 Charoenrat Road, Thungwatdon, Sathon Bangkok, TH 10120
• Contact: Pisut Chanwatarungkull
• Correspondent: Prabhat Garg; KUPS International 8516 Burning Tree Road, Bethesda, MD 20817
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-07-11
• Decision Date: 2019-04-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850281004002	K181844	000
00850281004408	K181844	000
00850281004156	K181844	000
00850281004095	K181844	000