OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)

Instruments, Surgical, Cardiovascular

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006).

Pre-market Notification Details

Device IDK964445
510k NumberK964445
Device Name:OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)
ClassificationInstruments, Surgical, Cardiovascular
Applicant DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
ContactRoger W Brick
CorrespondentRoger W Brick
DLP, INC. 620 WATSON S.W., P.O. BOX 409 Grand Rapids,  MI  49501
Product CodeDWS  
CFR Regulation Number870.4500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-06
Decision Date1997-01-30
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.