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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fiber, Medical, Absorbent
510(k) Number K770853
Device Name STERILE COTTON
Applicant
Stat Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stat Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5300
Classification Product Code
FRL  
Date Received05/09/1977
Decision Date 05/23/1977
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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