510(k) K970900

INSTRUMENT HOLDER by Contour Fabricators, Inc. — Product Code GCJ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 22, 1997
Date Received: March 11, 1997
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 Contour Fabricators, Inc.

K090773 — CFI ULTRASOUND PROBE DRAPE (September 18, 2009)
K971040 — CABLE HOLDER, SUCTION TUBE HOLDER (April 16, 1997)
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K964141 — GE STERILE DISPOSABLE EQUIPMENT COIL COVER (January 30, 1997)
K963453 — CFI RESTRAINT BELT (CFI-168) / CFI RESTRAINT BELT (CFI-4046) (November 15, 1996)
K820692 — BANDBAG, WRAP, STERILE (May 3, 1982)
K782155 — GENERAL EQUIPMENT COVER (January 17, 1979)

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