SURESCAN

Powered Laser Surgical Instrument

CLINICON CORP.

The following data is part of a premarket notification filed by Clinicon Corp. with the FDA for Surescan.

Pre-market Notification Details

• Device ID: K964831
• 510k Number: K964831
• Device Name: SURESCAN
• Classification: Powered Laser Surgical Instrument
• Applicant: CLINICON CORP. 2260 RUTHERFORD RD., #101 Carlsbad, CA 92008
• Contact: Alan Bunting
• Correspondent: Alan Bunting; CLINICON CORP. 2260 RUTHERFORD RD., #101 Carlsbad, CA 92008
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-12-02
• Decision Date: 1997-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850013050192	K964831	000