ROBICSEK PROBE/RETRACTOR

Dilator, Vessel, Surgical

BIO-VASCULAR, INC.

The following data is part of a premarket notification filed by Bio-vascular, Inc. with the FDA for Robicsek Probe/retractor.

Pre-market Notification Details

Device IDK910682
510k NumberK910682
Device Name:ROBICSEK PROBE/RETRACTOR
ClassificationDilator, Vessel, Surgical
Applicant BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
ContactSheryl A Krattley
CorrespondentSheryl A Krattley
BIO-VASCULAR, INC. 2670 PATTON RD. Saint Paul,  MN  55113
Product CodeDWP  
CFR Regulation Number870.4475 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-19
Decision Date1991-05-08

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