MONOPOLAR SURGICAL INSTRUMENTS

Electrosurgical, Cutting & Coagulation & Accessories

TNCO, INC.

The following data is part of a premarket notification filed by Tnco, Inc. with the FDA for Monopolar Surgical Instruments.

Pre-market Notification Details

• Device ID: K940552
• 510k Number: K940552
• Device Name: MONOPOLAR SURGICAL INSTRUMENTS
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: TNCO, INC. 15 COLEBROOK BLVD. P.O. BOX 231 Whitman, MA 02382
• Contact: Karin Dolan
• Correspondent: Karin Dolan; TNCO, INC. 15 COLEBROOK BLVD. P.O. BOX 231 Whitman, MA 02382
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-02-07
• Decision Date: 1994-05-05

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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