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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
510(k) Number K860099
Device Name MEDCO-SONIC NQ-2000
Applicant
Medco Products, Co., Inc.
1 Dock St.
Suite 402
Stamford,  CT  06902
Applicant Contact GARY I DANZIGER
Correspondent
Medco Products, Co., Inc.
1 Dock St.
Suite 402
Stamford,  CT  06902
Correspondent Contact GARY I DANZIGER
Regulation Number890.5300
Classification Product Code
IMI  
Date Received01/10/1986
Decision Date 04/09/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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