UNIPRO

Suture, Nonabsorbable, Synthetic, Polypropylene

UNITED MEDICAL INDUSTRIES CO. LTD.

The following data is part of a premarket notification filed by United Medical Industries Co. Ltd. with the FDA for Unipro.

Pre-market Notification Details

• Device ID: K042283
• 510k Number: K042283
• Device Name: UNIPRO
• Classification: Suture, Nonabsorbable, Synthetic, Polypropylene
• Applicant: UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY SANAYYA, OPPOSITE TO OBAIKAN Riyadh, Central Province, SA 11553
• Contact: Mohammed Azeez
• Correspondent: Mohammed Azeez; UNITED MEDICAL INDUSTRIES CO. LTD. 3RD INDUSTRIAL CITY SANAYYA, OPPOSITE TO OBAIKAN Riyadh, Central Province, SA 11553
• Product Code: GAW
• CFR Regulation Number: 878.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-08-24
• Decision Date: 2004-12-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06285379148865	K042283	000