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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K854920
Device Name THERAPY CASSETTS
Applicant
Alpha Therapeutic Corp.
P.O. Box 516
Rouses Point,  NY  12979
Applicant Contact STUART GILMAN
Correspondent
Alpha Therapeutic Corp.
P.O. Box 516
Rouses Point,  NY  12979
Correspondent Contact STUART GILMAN
Classification Product Code
MCU
Date Received12/10/1985
Decision Date 05/19/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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