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510(k) K970186

GI SUPPLY PARACENTESIS PUMP by Gi Supply — Product Code BTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 1997
Date Received
January 17, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Portable, Aspiration (Manual Or Powered)
Device Class
Class II
Regulation Number
878.4780
Review Panel
SU
Submission Type

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  • K031360 — GI SUPPLY BILIARY STENT (September 24, 2003)
  • K012411 — HP-ONE (September 25, 2001)
  • K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT (February 14, 1997)
  • K944903 — HP-FAST (April 20, 1995)
  • K931044 — OXY-BLOC (October 4, 1993)
  • K915816 — BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY (March 27, 1992)

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