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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861399
Device Name POWERSTIM ELECTRONIC MUSCLE STIMULATOR
Applicant
Bio-Med Systems Corp.
1560 Yonge St.
Ontario, Toronto,  CA M4T 2S9
Applicant Contact F. N LEHNER
Correspondent
Bio-Med Systems Corp.
1560 Yonge St.
Ontario, Toronto,  CA M4T 2S9
Correspondent Contact F. N LEHNER
Date Received04/15/1986
Decision Date 06/17/1986
Decision Substantially Equivalent (SESE)
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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