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510(k) K854068

EXTERNAL MECHANICAL FASTENER by Wells Johnson Co.

K854068 is an FDA 510(k) premarket notification submitted by Wells Johnson Co. for the device "EXTERNAL MECHANICAL FASTENER". The FDA issued a decision of Substantially Equivalent on November 22, 1985. Wells Johnson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1985
Date Received
October 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Wells Johnson Co.

  • K991437 — WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 (August 30, 1999)
  • K984448 — BIRCOLL BALLOON DISSECTOR (January 28, 1999)
  • K971580 — UAS ULTRASONIC ASPIRATOR SYSTEM (December 9, 1997)
  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K945500 — WELLS JOHNSON FIXATION SYSTEM (September 21, 1995)
  • K951519 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (June 14, 1995)
  • K945877 — WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT (March 2, 1995)
  • K945805 — WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE (December 13, 1994)
  • K843188 — WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP (September 20, 1984)
  • K832519 — ASPIRATING TUBING (October 20, 1983)

FDA data resources