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510(k) K030632

PD CASTA-H by Mountain Medico, Inc. — Product Code EJH

K030632 is an FDA 510(k) premarket notification submitted by Mountain Medico, Inc. for the device "PD CASTA-H". The FDA issued a decision of Substantially Equivalent on May 7, 2003. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Mountain Medico, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 2003
Date Received
February 28, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
Review Panel
DE
Submission Type

Other clearances by Mountain Medico, Inc.

  • K030416 — CERACAST-V (April 14, 2003)

Other clearances for product code EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)
  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)

FDA data resources