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mR BRio-Medical Research Ltd. P ~~~Parkmore
Business Park West, Galway, Ireland
Tel: +353 (0)
Fax: +353 (0)
This (k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. 1. Contact Details Name: Address: Deirdre Barrow Rio-Medical Research Ltd., Parkmore Business Park, West Galway, Ireland Telephone: Fax: E-Mail: Prepared: 4- 774300 + 774302 dbarrow(5)btmr.ie 25th January
Alternative Contact Person Title: Telephone Fax: E-Mail:
Michael O'Sullivan Quality Systems Manager + 774395 + 774301 mosullivan~bmr.ie
2. Device Name
Trade Name of Device: Common Name: Classification Name: Product Code: System Ultra, Type 390, Model E70/X70 Muscle Stimulator Stimulator, muscle, powered, for muscle conditioning NGX
3. Identification of Equivalent Legally Marketed Device
Device Trade Name: Manufacturer: 0(k) Nos: Slendertone System-Abs, Type 390 EIO/XIO device Rio-Medical Research Ltd K
Directors; T. Kirwan (Chairman). Dr. P. A. Smith (Mana~inQY) P.K. McDonnell ...