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510(k) K852105

MANAN UBK ULTRASONIC GUIDED BIOPSY KIT by Manan Manufacturing Co., Inc. — Product Code FCH

K852105 is an FDA 510(k) premarket notification submitted by Manan Manufacturing Co., Inc. for the device "MANAN UBK ULTRASONIC GUIDED BIOPSY KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on June 18, 1985. The device falls under product code FCH (Tray, Biopsy, Without Biopsy Instruments), a Class I device regulated under 21 CFR 876.4730. Manan Manufacturing Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
June 18, 1985
Date Received
May 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Biopsy, Without Biopsy Instruments
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type

Other clearances by Manan Manufacturing Co., Inc.

  • K873208 — MANAN TURNER STYLE NEEDLE (August 25, 1987)
  • K864405 — MANAN CONTRAST MEDIA ADMINISTRATION SET (December 18, 1986)
  • K863848 — MANAN BREST TUMOR LOCALIZATION NEEDLE (October 14, 1986)
  • K852018 — ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR (July 11, 1985)
  • K851833 — MANAN SELDINGER NEEDLE (July 11, 1985)
  • K851834 — MANAN GWI GUIDE WIRE INTRODUCER (July 11, 1985)
  • K851832 — NAMAN POTTS COURNAND NEEDLE (July 11, 1985)
  • K852501 — MYELOGRAM PROCEDURE TRAY (July 11, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K852426 — MANAN TROCAR STYLE BIOPSY NEEDLE (June 27, 1985)

Other clearances for product code FCH

  • K882673 — SIGMA 1 WOBBLER BIOPSY KIT (July 28, 1988)

FDA data resources