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510(k) K924223

MAR-MED LIVER STRAP by Mar-Med Co. — Product Code GDJ

K924223 is an FDA 510(k) premarket notification submitted by Mar-Med Co. for the device "MAR-MED LIVER STRAP". The FDA issued a decision of Substantially Equivalent on March 18, 1993. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1993
Date Received
August 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code GDJ

  • K153358 — Standard Clamp (May 2, 2016)
  • K930315 — THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE (February 4, 1994)
  • K922659 — GENERAL SURGERY CLAMP AND NEEDLE HOLDER (July 21, 1992)
  • K914913 — GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (December 31, 1991)
  • K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM (April 18, 1990)
  • K901107 — MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC (April 9, 1990)
  • K895726 — VESSEL OCCLUDER (October 24, 1989)
  • K895591 — SILICONE INSTRUMENT SHODS (October 20, 1989)
  • K882169 — SURGICAL DUCT CLAMP (VINE) (June 17, 1988)
  • K881741 — STUART LEE CLIP (June 3, 1988)

FDA data resources