Home / 510(k) Clearances / K822957

510(k) K822957

PURCAST by J. Aderer, Inc. — Product Code EJH

K822957 is an FDA 510(k) premarket notification submitted by J. Aderer, Inc. for the device "PURCAST". The FDA issued a decision of Substantially Equivalent on October 26, 1982. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. J. Aderer, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1982
Date Received
October 5, 1982
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 J. Aderer, Inc.

  • K822956 — G CAST (October 26, 1982)
  • K821798 — 82 ALLOY (July 13, 1982)
  • K821832 — DEGUCAST U (July 6, 1982)
  • K821590 — PORS-ON (June 14, 1982)
  • K821572 — DUALLOR 'R' (June 14, 1982)
  • K821407 — DEVA M (June 9, 1982)
  • K821446 — DEGUDENT 14 (June 9, 1982)
  • K821521 — STABILOR NF (June 9, 1982)
  • K821613 — E.G. BRIDGE GOLD (June 4, 1982)
  • K821299 — CER-MATE (May 28, 1982)

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)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)

FDA data resources