CATHETER REGULAR

Catheter, Peritoneal, Long-term Indwelling

ACCURATE SURGICAL INSTRUMENTS CO.

The following data is part of a premarket notification filed by Accurate Surgical Instruments Co. with the FDA for Catheter Regular.

Pre-market Notification Details

• Device ID: K813488
• 510k Number: K813488
• Device Name: CATHETER REGULAR
• Classification: Catheter, Peritoneal, Long-term Indwelling
• Applicant: ACCURATE SURGICAL INSTRUMENTS CO. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FJS
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-12-01
• Decision Date: 1981-12-31

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521056022	K813488	000