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510(k) K881796

UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE by Universal Medical Instrument Corp. — Product Code DWS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1988
Date Received
April 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

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  • K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (January 31, 1985)
  • K842259 — PCI W/CATH-SEAL SIDE FLOW FITTING (August 1, 1984)

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