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510(k) K894371

NIPRO SAFELET CATH by Pharma-Plast USA, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1989
Date Received
July 17, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Pharma-Plast USA, Inc.

  • K894373 — NIPRO DENTAL NEEDLE (October 13, 1989)
  • K894374 — BLOOD DRAWING NEEDLE (September 28, 1989)
  • K894372 — NIPRO NEEDLE HOLDER (September 28, 1989)
  • K884978 — PHARMA-PLAST INSULIN INFUSION SET (June 21, 1989)
  • K871263 — MULTIPLE PHARMA-PLAST TRACHEAL TUBE (June 15, 1987)
  • K852443 — PHARMA-PLAST CLINIPAK (October 16, 1985)
  • K852444 — ASIK 'ONCE' SYRINGE (October 16, 1985)
  • K852442 — PHARMA-PLAST NEEDLE (September 20, 1985)

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