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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K831236
Device Name BIPOLAR CARD
Applicant
New England Surgical Instrument Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr., Suite 200
Irvine,  CA  92618
Correspondent Contact Danielle Stowe
Regulation Number878.4400
Classification Product Code
GEI  
Date Received04/15/1983
Decision Date 06/02/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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