HOTIP HEMOSTATIC PROBE

Laser For Gastro-urology Use

TRIMEDYNE, INC.

The following data is part of a premarket notification filed by Trimedyne, Inc. with the FDA for Hotip Hemostatic Probe.

Pre-market Notification Details

Device IDK843628
510k NumberK843628
Device Name:HOTIP HEMOSTATIC PROBE
ClassificationLaser For Gastro-urology Use
Applicant TRIMEDYNE, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLNK  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-14
Decision Date1985-11-12

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