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510(k) K850636

SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-E by Fisher Scientific Co., LLC — Product Code KDX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
February 19, 1985
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

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Other clearances for product code KDX

  • K872625 — DECALCIFYING SOLUTION (August 6, 1987)
  • K842726 — DECALCIFIER SOLUTION (August 3, 1984)
  • K841488 — DECALCIFIER I (May 2, 1984)
  • K822036 — VOLU-SOL DECALCIFER (August 3, 1982)
  • K821443 — FORMICAL (June 2, 1982)
  • K811801 — CAL-RITE (July 28, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)