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510(k) K842012

UMI CURVED CHEMONUCLEOLYSIS NEEDLE by Universal Medical Instrument Corp. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 1984
Date Received
May 17, 1984
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 Universal Medical Instrument Corp.

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  • K935077 — CATH-SEAL (June 7, 1994)
  • K897128 — UMI BRAIDED CATHETER CONNECTOR (March 1, 1990)
  • K881796 — UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE (July 26, 1988)
  • K863178 — UMI STEERABLE TORQUE GUIDE WIRE (September 19, 1986)
  • K861984 — UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO (August 5, 1986)
  • K860168 — UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE (February 19, 1986)
  • K851088 — UMI ANGIOGRAPHIC CATHETER (May 16, 1985)
  • K850820 — PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID (April 10, 1985)
  • K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (January 31, 1985)

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