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510(k) K980738

PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION by Byron Medical — Product Code FRN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1998
Date Received
February 25, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type

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  • K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES (June 30, 1998)
  • K980392 — PSI-TEC ASPIRATOR (March 5, 1998)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973133 — BIG BAG 3000 PRESSURE INFUSOR (September 12, 1997)
  • K934179 — DISPOSABLE BAG DECANTER (May 23, 1994)
  • K934233 — ZARA ZONE IV MALAR IMPLANT MODIFICATION (February 3, 1994)
  • K933670 — BIOPSY PUNCH, SURGICAL (January 7, 1994)

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