STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN

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 Sterile Catheters-catheter Peritoneal Long-term In.

Pre-market Notification Details

• Device ID: K850214
• 510k Number: K850214
• Device Name: STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
• Classification: Catheter, Peritoneal, Long-term Indwelling
• Applicant: ACCURATE SURGICAL INSTRUMENTS CO. 590 RICHMOND STREET WEST Toronto Canado M5v 1y9, CA M5v 1y9
• Contact: Rothman
• Correspondent: Rothman; ACCURATE SURGICAL INSTRUMENTS CO. 590 RICHMOND STREET WEST Toronto Canado M5v 1y9, CA M5v 1y9
• Product Code: FJS
• CFR Regulation Number: 876.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-01-22
• Decision Date: 1985-07-26

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521004313	K850214	000