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1550 Regulatory Class 11 Product Code IYN IYO and LTX Dated September 9 2011 Received September 12 2011 Dear Mr. Also please note the regulation entitled Misbranding by reference to premarket notification 21 CER Part 807. Transducers The patient contact materials are biocompatible. All transducers used together with Pro Focus 2202 are Track 3 transducers. Summary of Technological Characteristics- Predicate Device Compared to Modified Device Modes of operation Ref. 1 Appendix G Intended Use...
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