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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 K771531
Device Name LAPAROTOMY SPONGES
Applicant
Surgilite Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Surgilite Intl., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
EFQ  
Date Received08/09/1977
Decision Date 09/06/1977
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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