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510(k) K911129

MMG BILE BAG by Medical Technologies of Georgia — Product Code EXF

K911129 is an FDA 510(k) premarket notification submitted by Medical Technologies of Georgia for the device "MMG BILE BAG". The FDA issued a decision of Substantially Equivalent on August 7, 1991. The device falls under product code EXF (Bag, Bile Collecting), a Class II device regulated under 21 CFR 876.5010. Medical Technologies of Georgia has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 1991
Date Received
March 14, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Bile Collecting
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Medical Technologies of Georgia

  • K080878 — MTG INSTANT CATHER (WITH AND WITHOUT KIT), MTG INSTANT CATH DELUXE (WITH AND WIT (July 17, 2008)
  • K973120 — READYCATH CATHETER (February 25, 1998)
  • K952392 — MLI SET (August 7, 1995)
  • 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)
  • K821853 — U-100 BAG (July 22, 1982)

Other clearances for product code EXF

  • K003078 — MERIT DRAINAGE DEPOT (December 11, 2000)
  • K990428 — DRAINAGE BAG (August 12, 1999)
  • K980005 — MANAN D BAG (January 30, 1998)
  • K961986 — MANAN D BAG (March 13, 1997)
  • K963849 — MANAN D BAG (December 13, 1996)
  • K943663 — NAVARRE 600 ML DRAINAGE BAG (September 8, 1994)
  • K903449 — URESIL TRU-CLOSE MULTI-PURPOSE DRAINAGE SET (September 12, 1990)
  • K901844 — URESIL TRU-CLOSE DRAINAGE BAG (June 1, 1990)

FDA data resources