GENTLE SLOPE

System, X-ray, Stationary

OCTOSTOP, INC.

The following data is part of a premarket notification filed by Octostop, Inc. with the FDA for Gentle Slope.

Pre-market Notification Details

• Device ID: K913711
• 510k Number: K913711
• Device Name: GENTLE SLOPE
• Classification: System, X-ray, Stationary
• Applicant: OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1
• Contact: Jean A Vezina
• Correspondent: Jean A Vezina; OCTOSTOP, INC. CASIER POSTAL 1476 SUCC. ST-LAURENT Montreal, Qc., CA H4l 4z1
• Product Code: KPR
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-08-07
• Decision Date: 1992-10-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B525FI060	K913711	000