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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 K781799
Device Name EKG, SWITCHING BLADE AND PENS
Applicant
Bionex, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bionex, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/23/1978
Decision Date 02/26/1979
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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