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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Mattress, Flotation Therapy, Non-Powered
510(k) Number K802781
Device Name BEDDING PADS EGGCREATE PADS
Applicant
Leemart Bedding Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Leemart Bedding Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5150
Classification Product Code
IKY  
Date Received11/05/1980
Decision Date 12/10/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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