UNSTERILIZED LAPAROTOMY SPONGES (CHINA)

Gauze/sponge, Internal, X-ray Detectable

ROBERT I. CHIEN & ASSOC., INC.

The following data is part of a premarket notification filed by Robert I. Chien & Assoc., Inc. with the FDA for Unsterilized Laparotomy Sponges (china).

Pre-market Notification Details

Device IDK811632
510k NumberK811632
Device Name:UNSTERILIZED LAPAROTOMY SPONGES (CHINA)
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant ROBERT I. CHIEN & ASSOC., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGDY  
CFR Regulation Number878.4450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-06-09
Decision Date1981-09-11

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