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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Device, Iontophoresis, Other Uses
510(k) Number K900363
Device Name NEOPHOR-MC
Applicant
L.S. Scientific
41 Polk St.
Riverside,  NJ  08075
Applicant Contact RON SALESKY
Correspondent
L.S. Scientific
41 Polk St.
Riverside,  NJ  08075
Correspondent Contact RON SALESKY
Regulation Number890.5525
Classification Product Code
EGJ  
Date Received01/25/1990
Decision Date 04/25/1990
Decision Substantially Equivalent - With Drug (SESD)
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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