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510(k) K934320

MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION by Mentor O & O, Inc. — Product Code HQR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 1994
Date Received
September 3, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Cautery, Radiofrequency, Ac-Powered
Device Class
Class II
Regulation Number
886.4100
Review Panel
OP
Submission Type

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  • K941495 — RETURN PATH DIATHERMY HANDLE (July 15, 1994)
  • K895800 — ADVANCED SURGICAL SOLID STATE BIPOLAR COAGULATOR (January 22, 1990)
  • K870194 — UNITED SURGICAL CORP. DIATHERMIC PLUS (February 20, 1987)