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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Protector, Skin Pressure
510(k) Number K801195
Device Name DERMALEX OR NATRAWOOL SKIN PRESSURE PROT
Applicant
Stock Wild & Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stock Wild & Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6450
Classification Product Code
FMP  
Date Received05/16/1980
Decision Date 06/09/1980
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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