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506J Device List
… Anesthesia Masks BSJ MASK, GAS, ANESTHETIC Angioplasty Catheters DRB STYLET, CATHETER DYB INTRODUCER, CATHETER ONU … Monitors GWM DEVICE, MONITORING, INTRACRANIAL PRESSURE Intrauterine Tamponade Balloon OQY INTRAUTERINE TAMPONADE BALLOON Intravenous (IV) Containers …
Tenderneeds Fertility LLC - 603383 - 04/13/2020
… importer of devices and a manufacturer of several types of Intrauterine Insemination (IUI) and Intracervical … classified under 21 CFR 884.6110, Assisted Reproduction Catheters are class II, prescription devices that require … in your firm’s IUI kits intended for use in human intrauterine insemination. • Based on evidence collected …
December 2022 510(K) Clearances
… CA 95050 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: Rejoni Intrauterine Catheter Rejoni, Inc. 510(k) NO: K222798 … FROM FDA DEVICE: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters Spectranetics Inc. 510(k) NO: K222837 (Special) …