MRI FASTSYSTEM RETRACTOR SYSTEM

Retractor

OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Omni-tract Surgical, Div. Minn. Scientific, Inc. with the FDA for Mri Fastsystem Retractor System.

Pre-market Notification Details

Device IDK001339
510k NumberK001339
Device Name:MRI FASTSYSTEM RETRACTOR SYSTEM
ClassificationRetractor
Applicant OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis,  MN  55413 -1660
ContactCatherine Miller
CorrespondentCatherine Miller
OMNI-TRACT SURGICAL, DIV. MINN. SCIENTIFIC, INC. 1100 NEW BRIGHTON BLVD. Minneapolis,  MN  55413 -1660
Product CodeGAD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-04-27
Decision Date2000-05-17

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