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510(k) K901995

PLEURA BIOPSY DEVICE by Mill-Rose Laboratory — Product Code GDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1990
Date Received
May 2, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Mill-Rose Laboratory

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  • K983124 — MILL-ROSE LABORATORIES TRANSBRONCHIAL NEEDLE ASPIRATION (TBNA) CYTOLOGY PROCEDUR (October 30, 1998)
  • K971275 — MILL-ROSE DISPOSABLE POLYPECTOMY SNARE (May 23, 1997)
  • K962736 — MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE (July 29, 1996)
  • K960880 — MILL-ROSE BLIND MICROBIOLOGY BRUSH (April 29, 1996)
  • K954519 — WANG TRANSENDOSCOPIC ASPIRATION NEEDLE (December 22, 1995)
  • K951600 — MILL-ROSE ROTATABLE POLYPECTOMY SNARE (December 18, 1995)
  • K954745 — MILL-ROSE RIGID SCOPE CLEANING BRUSHES (November 27, 1995)
  • K951051 — RITE-BITE BIOPSY FORCEPS (March 24, 1995)
  • K951048 — RITE-BITE BIOPSY FORCEPS (March 15, 1995)

Other clearances for product code GDM

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  • K953082 — ILIAC CREST BONE MARROW ASPIRATION NEEDLE (September 22, 1995)
  • K953064 — BIOACCESS MARROW HARVEST SYSTEM (August 7, 1995)
  • K936207 — ENDO-NEEDLE INSTRUMENT (June 16, 1994)
  • K930160 — ILLINOIS STERNAL/ILIAC ASPIRATION NEEDLE (July 6, 1993)
  • K923872 — BONE MARROW BIOPSY SYSTEM (December 15, 1992)
  • K915572 — BECTON DICKINSON MODIFIED MENGHINI NEEDLE (February 3, 1992)
  • K904667 — NA NEEDLES (December 12, 1990)
  • K903747 — ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U (October 31, 1990)