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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Diagnostic
510(k) Number K842262
FOIA Releasable 510(k) K842262
Device Name PIRD-Y
Applicant
Pirdy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Pirdy, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.1850
Classification Product Code
ISB  
Date Received06/07/1984
Decision Date 06/28/1984
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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