LATEX CONDOM

Condom

SURETEX, LTD.

The following data is part of a premarket notification filed by Suretex, Ltd. with the FDA for Latex Condom.

Pre-market Notification Details

• Device ID: K941258
• 510k Number: K941258
• Device Name: LATEX CONDOM
• Classification: Condom
• Applicant: SURETEX, LTD. 71 SOI SAP, SIPRAYA, BANGKOK 10500, Thailand, TH 10500
• Contact: Ashok Murkerjee
• Correspondent: Ashok Murkerjee; SURETEX, LTD. 71 SOI SAP, SIPRAYA, BANGKOK 10500, Thailand, TH 10500
• Product Code: HIS
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-16
• Decision Date: 1995-12-06

NIH GUDID Devices

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