ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM

Apparatus, Autotransfusion

TRANSFUSION TECHNOLOGIES CORP.

The following data is part of a premarket notification filed by Transfusion Technologies Corp. with the FDA for Orthopedic Perioperative Autotransfusion (orthopat) System.

Pre-market Notification Details

Device IDK982660
510k NumberK982660
Device Name:ORTHOPEDIC PERIOPERATIVE AUTOTRANSFUSION (ORTHOPAT) SYSTEM
ClassificationApparatus, Autotransfusion
Applicant TRANSFUSION TECHNOLOGIES CORP. 9 ERIE DR. Natick,  MA  01760
ContactJohn J Sokolowski
CorrespondentJohn J Sokolowski
TRANSFUSION TECHNOLOGIES CORP. 9 ERIE DR. Natick,  MA  01760
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-30
Decision Date1999-03-30
Summary:summary

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