FDA 510(k) K051587, TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470, by Tracoe Medical GmbH
FDA 510(k) K051587, TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470, by Tracoe Medical GmbH
Device Classification Name: Tube, Tracheostomy (W/Wo Connector)
510(k) Number: K051587
Device Name: TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470
Applicant: Tracoe Medical GmbH
Regulation Number: 868.5800
Classification Product Code: BTO
Date Received: 06/15/2005
Decision Date: 10/25/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
510k Review Panel: Anesthesiology
Total number of pages: 248
Fully redacted pages: 108
Content pages: 140
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