BIPOLAR CARD

Electrosurgical, Cutting & Coagulation & Accessories

NEW ENGLAND SURGICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Bipolar Card.

Pre-market Notification Details

• Device ID: K831236
• 510k Number: K831236
• Device Name: BIPOLAR CARD
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: NEW ENGLAND SURGICAL INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-04-15
• Decision Date: 1983-06-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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