510(k) K791327

ARGYLE TAUSSIG CULTURE CATHETER by Sherwood Medical Co. — Product Code KTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1979
Date Received
July 16, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tube, Aspirating, Bronchoscope, Rigid
Device Class
Class II
Regulation Number
874.4680
Review Panel
EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).