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510(k) K914329

SURGITRON UNITS- ELECTRO SURG SYST GYN INDICATION by Ellman Intl. Mfg., Inc. — Product Code HGI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1992
Date Received
September 27, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocautery, Gynecologic (And Accessories)
Device Class
Class II
Regulation Number
884.4120
Review Panel
OB
Submission Type

Other clearances by Ellman Intl. Mfg., Inc.

  • K911461 — SURGITRON (April 25, 1991)

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