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510(k) K913317

MEGA ARTHROGRAM KIT by Mega Medical, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1991
Date Received
July 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Mega Medical, Inc.

  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 1992)
  • K913397 — MEGA ANGIOGRAM KIT (October 31, 1991)
  • K912445 — MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT (October 18, 1991)
  • K913382 — MEGA PARACENTESIS KIT (October 8, 1991)
  • K912322 — MEGA SPINAL ANESTHESIA KIT (September 26, 1991)
  • K912564 — MEGA PERICARDIOCENTESIS KIT (September 5, 1991)

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