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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory, Surgical Apparel
510(k) Number K944276
Device Name SLOAN STA-DRI BOOTLEG LEGGING
Applicant
Sloan Corp.
11033 W. Maple Rd.
Omaha,  NE  68164
Applicant Contact STEWART SLOAN
Correspondent
Sloan Corp.
11033 W. Maple Rd.
Omaha,  NE  68164
Correspondent Contact STEWART SLOAN
Regulation Number878.4040
Classification Product Code
LYU  
Date Received08/30/1994
Decision Date 07/31/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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