KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)

Colonoscope And Accessories, Flexible/rigid

PENTAX PRECISION INSTRUMENT CORP.

The following data is part of a premarket notification filed by Pentax Precision Instrument Corp. with the FDA for Kec-3840l/f, Video Colonoscope (*l Or F In Model Number Denotes Length).

Pre-market Notification Details

• Device ID: K961570
• 510k Number: K961570
• Device Name: KEC-3840L/F, VIDEO COLONOSCOPE (*L OR F IN MODEL NUMBER DENOTES LENGTH)
• Classification: Colonoscope And Accessories, Flexible/rigid
• Applicant: PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025
• Contact: Paul Silva
• Correspondent: Paul Silva; PENTAX PRECISION INSTRUMENT CORP. 3117 COMMERCE PKWY. Miramar, FL 33025
• Product Code: FDF
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-04-23
• Decision Date: 1996-06-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04961333232314	K961570	000
04961333232246	K961570	000
04961333224623	K961570	000
04961333224609	K961570	000
04961333085149	K961570	000