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510(k) K080878

MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WITHOUT KIT) by Medical Technologies of Georgia, Inc. — Product Code KOD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2008
Date Received
March 31, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Medical Technologies of Georgia, Inc.

  • K973120 — READYCATH CATHETER (February 25, 1998)
  • K952392 — MLI SET (August 7, 1995)
  • K911129 — MMG BILE BAG (August 7, 1991)
  • K873136 — MMG CATH-N-PLACE (September 9, 1987)
  • K871949 — MMG DELEE SUCTION CATHETER W/MUCOUS TRAP (June 15, 1987)
  • K854821 — MMG EXTERNAL FEMALE CATHETERS (April 24, 1986)
  • K854660 — THE MMG ENTERAL FEEDING ADMINISTRATION SET (January 21, 1986)
  • K840839 — MMG FOLEY CATHETER (April 17, 1984)
  • K840897 — OXYGEN TUBING (March 16, 1984)
  • K821854 — U-200 BAG (July 22, 1982)

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