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510(k) K944307

JAMES LECKEY PRONE STANDER by James Leckey Design — Product Code INW

K944307 is an FDA 510(k) premarket notification submitted by James Leckey Design for the device "JAMES LECKEY PRONE STANDER". The FDA issued a decision of Substantially Equivalent on December 22, 1994. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750. James Leckey Design has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1994
Date Received
September 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
Review Panel
PM
Submission Type

Other clearances by James Leckey Design

  • K944308 — JAMES LECKEY FREE STANDER (December 22, 1994)

Other clearances for product code INW

  • K944308 — JAMES LECKEY FREE STANDER (December 22, 1994)
  • K943974 — EURO TECH MARQUISE CHIROPRACTIC TABLE (September 29, 1994)
  • K943975 — EURO TECH PLATINUM CHIROPRACTIC TABLE (September 29, 1994)
  • K940238 — TUMBLE FORMS JUNIOR TRISTANDER (March 7, 1994)
  • K932233 — ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 (July 22, 1993)
  • K932231 — ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 (July 22, 1993)
  • K932234 — PROFESSIONAL & ECONMY TILT TABLE 9500 9520 (July 22, 1993)
  • K932238 — ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERS (July 22, 1993)
  • K931635 — TREATMENT TABLES, MANUALLY ACTIVATED (July 21, 1993)
  • K926026 — DESKS (March 24, 1993)

FDA data resources