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510(k) K852443

PHARMA-PLAST CLINIPAK by Pharma-Plast USA, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
June 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Pharma-Plast USA, Inc.

  • K894371 — NIPRO SAFELET CATH (October 25, 1989)
  • 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)
  • K852444 — ASIK 'ONCE' SYRINGE (October 16, 1985)
  • K852442 — PHARMA-PLAST NEEDLE (September 20, 1985)

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