510(k) K072912

SOPRO 225 DUAL HALOGEN LIGHT SOURCE by Sopro — Product Code GCJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 16, 2007
Date Received: October 12, 2007
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Laparoscope, General & Plastic Surgery
Device Class: Class II
Regulation Number: 876.1500
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 Sopro

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K121685 — SOPROCARE (March 12, 2013)
K103813 — SOPRO 281 (March 22, 2011)
K092329 — SOPIX 2 (July 20, 2010)
K092583 — SOPROLIFE (January 13, 2010)
K082796 — SOPRO 184 CAMERA (April 1, 2009)
K080122 — SOPRO 670 ARTHROSCOPIC PUMP (July 11, 2008)
K070783 — SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR (December 13, 2007)
K070102 — SOPRO 162 CAMERA (February 20, 2007)
K031593 — SOPRO 61D (September 16, 2003)

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