TURBO 25/30

Scaler, Ultrasonic

PARKELL, INC.

The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Turbo 25/30.

Pre-market Notification Details

Device IDK950256
510k NumberK950256
Device Name:TURBO 25/30
ClassificationScaler, Ultrasonic
Applicant PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale,  NY  11735
ContactNelson J Gendusa
CorrespondentNelson J Gendusa
PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale,  NY  11735
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-23
Decision Date1995-04-04

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