INSERTION

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 Insertion.

Pre-market Notification Details

• Device ID: K920515
• 510k Number: K920515
• Device Name: INSERTION
• 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: 1992-02-04
• Decision Date: 1992-05-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521004771	K920515	000
10884521004764	K920515	000
10884521811256	K920515	000
10884521811249	K920515	000