STERILE LAPAROTOMY SPONGES-X-RAY DETECT

Gauze/sponge, Internal, X-ray Detectable

MEDSPEC CORP.

The following data is part of a premarket notification filed by Medspec Corp. with the FDA for Sterile Laparotomy Sponges-x-ray Detect.

Pre-market Notification Details

Device IDK812710
510k NumberK812710
Device Name:STERILE LAPAROTOMY SPONGES-X-RAY DETECT
ClassificationGauze/sponge, Internal, X-ray Detectable
Applicant MEDSPEC CORP. 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 Received1981-09-24
Decision Date1981-11-02

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