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510(k) K821443

FORMICAL by Lerner Laboratories, Inc. — Product Code KDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1982
Date Received
May 14, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Decalcifier, Acid Containing
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
Submission Type

Other clearances by Lerner Laboratories, Inc.

  • K853694 — XYLENE SUBSTITUTE (October 22, 1985)
  • K854083 — XYLENE SUBSTITUTE MONTANT (October 22, 1985)
  • K761000 — PAP-TRAY I (CATALOG #C600-1) (December 6, 1976)
  • K761001 — PAP-TRAY II (CATALOG #C600-2) (December 6, 1976)

Other clearances for product code KDX

  • K872625 — DECALCIFYING SOLUTION (August 6, 1987)
  • K850636 — SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E (March 20, 1985)
  • K842726 — DECALCIFIER SOLUTION (August 3, 1984)
  • K841488 — DECALCIFIER I (May 2, 1984)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K811801 — CAL-RITE (July 28, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)