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510(k) K842001

LIVER BIOPSY TRAY by Jayco Pharmaceuticals

K842001 is an FDA 510(k) premarket notification submitted by Jayco Pharmaceuticals for the device "LIVER BIOPSY TRAY". The FDA issued a decision of Substantially Equivalent on October 15, 1984. Jayco Pharmaceuticals has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1984
Date Received
May 16, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Jayco Pharmaceuticals

  • K844690 — ENDOSCOPIC MULTIPLE BIOPSY INSTRUMENT (January 2, 1985)
  • K844689 — ENDOSCOPIC MANUAL AIR INSUFFLATOR (January 2, 1985)
  • K844691 — ENDOSCOPIC ASPIRATION CATHETER SET (January 2, 1985)
  • K842009 — ABDOMINAL PARACENTESIS TRAY (October 23, 1984)
  • K841258 — FOREIGN BODY PROTECTOR (July 9, 1984)
  • K840800 — POLYP-SAVER SLEVE (March 23, 1984)
  • K830781 — ENDO-GUARD (March 31, 1983)
  • K810875 — FECAL STAINING KIT (May 1, 1981)

FDA data resources