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510(k) K860582

TBI NEEDLE by Hobbs Medical, Inc. — Product Code GAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1986
Date Received
February 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Aspiration And Injection, Disposable
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K893729 — HOBBS MEDICAL MICROBIOLOGY BRUSH (August 28, 1989)
  • K872509 — LINDEN STONE EXTRACTION BALLOON (September 22, 1987)

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  • K983200 — INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX (December 11, 1998)
  • K974741 — MANAN ACCURA NEEDLE (January 8, 1998)
  • K962425 — BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) (September 11, 1996)
  • K961959 — MD TECH BIOPSY SET FOR BONE AND BONE MARROW (July 19, 1996)
  • K945109 — MONOJECT BONE MARROW BIOPSY TRAYS (November 14, 1994)
  • K940025 — MANAN BONE MARROW HARVEST NEEDLES (February 25, 1994)