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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, x-ray detectable
510(k) Number K811632
Device Name UNSTERILIZED LAPAROTOMY SPONGES (CHINA)
Applicant
ROBERT I. CHIEN & ASSOC., INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Correspondent
ROBERT I. CHIEN & ASSOC., INC.
803 N. Front St. Suite 3
mchenry,  IL  60050
Regulation Number878.4450
Classification Product Code
GDY  
Date Received06/09/1981
Decision Date 09/11/1981
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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