General & Plastic Surgery Instruments

Laparoscope, General & Plastic Surgery

Sontec Instruments Inc.

The following data is part of a premarket notification filed by Sontec Instruments Inc. with the FDA for General & Plastic Surgery Instruments.

Pre-market Notification Details

• Device ID: K152400
• 510k Number: K152400
• Device Name: General & Plastic Surgery Instruments
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: Sontec Instruments Inc. 7248 South Tucson Way Centennial, CO 80112
• Contact: Stefan M. Scanlan
• Correspondent: Charles M. (mike) Hart; HART Consulting LLC 2964 Redhaven Way Littleton, CO 80126
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-08-25
• Decision Date: 2016-01-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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