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510(k) K852018

ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR by Manan Manufacturing Co., Inc.

K852018 is an FDA 510(k) premarket notification submitted by Manan Manufacturing Co., Inc. for the device "ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR". The FDA issued a decision of Substantially Equivalent (with conditions) on July 11, 1985. Manan Manufacturing Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESD (Substantially Equivalent (with conditions))
Decision Date
July 11, 1985
Date Received
May 8, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K851832 — NAMAN POTTS COURNAND NEEDLE (July 11, 1985)
  • K851834 — MANAN GWI GUIDE WIRE INTRODUCER (July 11, 1985)
  • K851833 — MANAN SELDINGER NEEDLE (July 11, 1985)
  • K852501 — MYELOGRAM PROCEDURE TRAY (July 11, 1985)
  • K852427 — MANAN SPINAL NEEDLE (June 27, 1985)
  • K852428 — MANAN EPIDURAL NEEDLE (June 27, 1985)
  • K852426 — MANAN TROCAR STYLE BIOPSY NEEDLE (June 27, 1985)

FDA data resources