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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauze/Sponge, Internal
510(k) Number K823058
Device Name DOSOMETRIC RELEASE STERILIZATION
Applicant
Stan-Pak Ent.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Stan-Pak Ent.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
EFQ  
Date Received10/18/1982
Decision Date 12/09/1982
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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