BOVIE ULTRASONIC SURGICAL SYSTEM

Device, Neurosurgical Fragmentation And Aspiration

CLINICAL TECHNOLOGY CORP.

The following data is part of a premarket notification filed by Clinical Technology Corp. with the FDA for Bovie Ultrasonic Surgical System.

Pre-market Notification Details

Device IDK855138
510k NumberK855138
Device Name:BOVIE ULTRASONIC SURGICAL SYSTEM
ClassificationDevice, Neurosurgical Fragmentation And Aspiration
Applicant CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester,  NY  14692
ContactScoville, Jr
CorrespondentScoville, Jr
CLINICAL TECHNOLOGY CORP. 3750 MONROE AVE. P.O. BOX 23245 Rochester,  NY  14692
Product CodeLBK  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-23
Decision Date1986-11-10

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