BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE

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 Electrosurgical Intraocular Probe.

Pre-market Notification Details

• Device ID: K864402
• 510k Number: K864402
• Device Name: BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE
• Classification: Electrosurgical, Cutting & Coagulation & Accessories
• Applicant: NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370
• Contact: Richard Beane
• Correspondent: Richard Beane; NEW ENGLAND SURGICAL INSTRUMENT CORP. P.O. BOX 35 83 EAST WATER STREET Rockland, MA 02370
• Product Code: GEI
• CFR Regulation Number: 878.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-11-06
• Decision Date: 1987-01-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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00841019103746	K864402	000
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