REPROCESSED HARMONIC SCALPELS

Scalpel, Ultrasonic, Reprocessed

STERILMED, INC.

The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Scalpels.

Pre-market Notification Details

Device IDK050343
510k NumberK050343
Device Name:REPROCESSED HARMONIC SCALPELS
ClassificationScalpel, Ultrasonic, Reprocessed
Applicant STERILMED, INC. 11400 73RD. AVE. N. STE. 100 Maple Grove,  MN  55369
ContactBruce Lester
CorrespondentBruce Lester
STERILMED, INC. 11400 73RD. AVE. N. STE. 100 Maple Grove,  MN  55369
Product CodeNLQ  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-02-11
Decision Date2005-04-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10888551010900 K050343 000
10888551010115 K050343 000
10888551010092 K050343 000

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