SURGIKOS NEUTRALON BR. SURGEON'S GLOVE

Surgeon's Gloves

SURGIKOS, INC.

The following data is part of a premarket notification filed by Surgikos, Inc. with the FDA for Surgikos Neutralon Br. Surgeon's Glove.

Pre-market Notification Details

Device IDK800152
510k NumberK800152
Device Name:SURGIKOS NEUTRALON BR. SURGEON'S GLOVE
ClassificationSurgeon's Gloves
Applicant SURGIKOS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKGO  
CFR Regulation Number878.4460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-01-22
Decision Date1980-02-19

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