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510(k) K912564

MEGA PERICARDIOCENTESIS KIT by Mega Medical, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 1991
Date Received
June 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

Other clearances by Mega Medical, Inc.

  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 1992)
  • K913317 — MEGA ARTHROGRAM KIT (October 31, 1991)
  • 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)

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