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510(k) K982733

OLYMPUS MH-246R BALLOON SHEATH, FOR BRONCHIAL USE by The Olympus Optical Co. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 1998
Date Received
August 5, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • K012073 — OLYMPUS SPRAY CATHETER PW-6C-1 (August 10, 2001)
  • K011869 — XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT (July 25, 2001)
  • K011149 — DISPOSABLE BENDING CANNULA PR-233Q (May 15, 2001)

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