510(k) Premarket Notification

• Device Classification Name: instrument, shunt system implantation
• 510(k) Number: K853370
• Device Name: H-H CATHETER PASSERS(TACL DESIGN
• Applicant: HOLTER-HAUSNER INTL.; THIRD AND MILL STREETS; P.O. BOX 100; BRIDGEPORT, PA 19405
• Applicant Contact: JOHN R BOLLES
• Correspondent: HOLTER-HAUSNER INTL.; THIRD AND MILL STREETS; P.O. BOX 100; BRIDGEPORT, PA 19405
• Correspondent Contact: JOHN R BOLLES
• Regulation Number: 882.4545
• Classification Product Code: GYK
• Date Received: 08/12/1985
• Decision Date: 09/18/1985
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Neurology
• 510k Review Panel: Neurology
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls