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510(k) K852442

PHARMA-PLAST NEEDLE by Pharma-Plast USA, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1985
Date Received
June 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
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)
  • K852443 — PHARMA-PLAST CLINIPAK (October 16, 1985)
  • K852444 — ASIK 'ONCE' SYRINGE (October 16, 1985)

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