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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Therapeutic, Electric
510(k) Number K873819
Device Name MODIFIED STRESS MACHINE
Applicant
S.J.F., Inc.
85 Dobson Rd.
Mars,  PA  16046
Applicant Contact F CURRAN
Correspondent
S.J.F., Inc.
85 Dobson Rd.
Mars,  PA  16046
Correspondent Contact F CURRAN
Regulation Number890.5660
Classification Product Code
ISA  
Date Received09/21/1987
Decision Date 01/22/1988
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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