510(k) K961473

HM-88011 SOLID STATE ELECTR SURGICAL UNIT by Hill-Med, Inc. — Product Code GEI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 7, 1996
Date Received: April 17, 1996
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electrosurgical, Cutting & Coagulation & Accessories
Device Class: Class II
Regulation Number: 878.4400
Review Panel: SU
Submission Type

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Hill-Med, Inc.

K993991 — HM-930 ELECTROSURGICAL UNIT (May 30, 2000)
K981781 — ELECTROSURGICAL UNIT (December 4, 1998)
K951718 — HM-SPIRO (December 20, 1995)
K940140 — HM-CRYO (June 27, 1994)
K932896 — HM-0690 COLPOSCOPE (March 23, 1994)
K932782 — HM-0660 (March 23, 1994)
K932817 — HM-880 I (March 9, 1994)
K932818 — HM-880 (February 25, 1994)
K932720 — HM-0970 (September 7, 1993)

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