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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name beads, hydrophilic, for wound exudate absorption
510(k) Number K780775
Device Name MEDICAL PROTEIN HYDROLYSATE REVITAL
Applicant
ROBERTSON RESOURCES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ROBERTSON RESOURCES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received05/04/1978
Decision Date 11/30/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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