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510(k) K912159

MAJOR SET-UP TRAY by Medical Device Inspection Co., Inc. — Product Code GCJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 1991
Date Received
May 16, 1991
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 Medical Device Inspection Co., Inc.

  • K945826 — J & J I-330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE SOFT (August 4, 1995)
  • K932072 — JARIT SURGICAL INSTRUMENTS (January 11, 1994)
  • K931594 — THERA-TURN CM-1000 MATTRESS OVERLAY SYSTEM (December 21, 1993)
  • K933581 — POWERMATIC TREATMENT TABLE (November 5, 1993)
  • K933580 — POWER WORK TABLE (November 5, 1993)
  • K933578 — POWERMATIC MAT PLATFORM (November 5, 1993)
  • K933577 — POWERMATIC EXAMINATION TABLE (September 30, 1993)
  • K922045 — SHOWER CHAIRS (May 26, 1992)
  • K912075 — C-SECTION TRAY (April 7, 1992)
  • K914174 — STERILE DISPOSABLE WET SKIN SCRUB TRAY (February 24, 1992)

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