STERILE LAPAROTOMY SPONGES

Gauze/sponge, Internal

CYPRESS MEDICAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Sterile Laparotomy Sponges.

Pre-market Notification Details

Device IDK890770
510k NumberK890770
Device Name:STERILE LAPAROTOMY SPONGES
ClassificationGauze/sponge, Internal
Applicant CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry,  IL  60050
ContactVarun Soni
CorrespondentVarun Soni
CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry,  IL  60050
Product CodeEFQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-14
Decision Date1989-03-14

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