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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Gel, Electrosurgical
510(k) Number K923647
Device Name RFG-DGP DISPOSABLE GROUNDING PADS
Applicant
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Applicant Contact LINDA JALBERT
Correspondent
Radionics, Inc.
P.O. Box 438
76 Cambridge St.
Burlington,  MA  01803
Correspondent Contact LINDA JALBERT
Regulation Number878.4400
Classification Product Code
JOT  
Date Received07/21/1992
Decision Date 11/09/1992
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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