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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pack, Heat, Moist
510(k) Number K950701
Device Name WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER
Applicant
Wahl Clipper Corp.
2900 N. Locust St.
P.O. Box 578
Steriling,  IL  61081
Applicant Contact CYNTHIA DE LONG
Correspondent
Wahl Clipper Corp.
2900 N. Locust St.
P.O. Box 578
Steriling,  IL  61081
Correspondent Contact CYNTHIA DE LONG
Regulation Number890.5730
Classification Product Code
IMA  
Subsequent Product Codes
IME   LYG  
Date Received02/15/1995
Decision Date 03/24/1995
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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