ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF

Instrument, Ultrasonic Surgical

MISONIX, INC.

The following data is part of a premarket notification filed by Misonix, Inc. with the FDA for Ultrasonic Surgical Aspirator System, Model Fs 1000 Rf.

Pre-market Notification Details

• Device ID: K062471
• 510k Number: K062471
• Device Name: ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
• Classification: Instrument, Ultrasonic Surgical
• Applicant: MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735
• Contact: Ronald R Manna
• Correspondent: Ronald R Manna; MISONIX, INC. 1938 NEW HIGHWAY Farmingdale, NY 11735
• Product Code: LFL
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-08-24
• Decision Date: 2006-10-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841626100008	K062471	000
00841626101500	K062471	000
00841626101449	K062471	000
00841626101302	K062471	000
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00841626101586	K062471	000
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00841626100015	K062471	000
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00841626101746	K062471	000
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00841626101708	K062471	000
00841626101685	K062471	000
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00841626101777	K062471	000
20841626100576	K062471	000