Home / 510(k) Clearances / K872625

510(k) K872625

DECALCIFYING SOLUTION by Stephens Scientific — Product Code KDX

K872625 is an FDA 510(k) premarket notification submitted by Stephens Scientific for the device "DECALCIFYING SOLUTION". The FDA issued a decision of Substantially Equivalent on August 6, 1987. The device falls under product code KDX (Solution, Decalcifier, Acid Containing), a Class I device regulated under 21 CFR 864.4010. Stephens Scientific has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 1987
Date Received
July 6, 1987
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 Stephens Scientific

  • K893772 — TISSUE EMBEDDING MEDIUM (June 22, 1989)
  • K881359 — DECALCIFYING SOLUTION II (April 19, 1988)
  • K832011 — AMERI CLEAR (August 12, 1983)

Other clearances for product code KDX

  • 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)
  • K821443 — FORMICAL (June 2, 1982)
  • K811801 — CAL-RITE (July 28, 1981)
  • K810836 — DECALCIFIER II (April 23, 1981)

FDA data resources