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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Muscle Monitoring
510(k) Number K850425
Device Name DENTAL ANESTHESIA APPARATUS
Applicant
Pain Prevention, Inc.
200 W. Madison St.
Suite 3200
Chicago,  IL  60606
Applicant Contact RICHARD D HARRIS
Correspondent
Pain Prevention, Inc.
200 W. Madison St.
Suite 3200
Chicago,  IL  60606
Correspondent Contact RICHARD D HARRIS
Regulation Number890.1375
Classification Product Code
KZM  
Date Received02/04/1985
Decision Date 10/09/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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