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510(k) K843557

K-APATITE 20-40 MESH K-APATITE 40-60 by Katecho, Inc. — Product Code ELE

K843557 is an FDA 510(k) premarket notification submitted by Katecho, Inc. for the device "K-APATITE 20-40 MESH K-APATITE 40-60". The FDA issued a decision of Substantially Equivalent on November 30, 1984. The device falls under product code ELE (Implant, Subperiosteal), a Class II device regulated under 21 CFR 872.3645. Katecho, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1984
Date Received
September 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Subperiosteal
Device Class
Class II
Regulation Number
872.3645
Review Panel
DE
Submission Type

Other clearances by Katecho, Inc.

  • K012404 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 (October 12, 2001)
  • K010543 — KM-30 TENS ELECTRODE (May 23, 2001)
  • K003228 — K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A (December 14, 2000)
  • K002806 — K-DEFIB/PACE, MODEL KDP-60A (November 21, 2000)
  • K000870 — KM-10 TENS ELECTRODE (November 7, 2000)
  • K993745 — K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80 (February 3, 2000)
  • K991007 — K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60 (August 23, 1999)
  • K981737 — K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60 (December 9, 1998)
  • K954504 — K-DEFIB/PACE PEDIATRIC ELECTRODE (November 17, 1995)
  • K934692 — K-DEFIB/PACE PEDIATRIC ELECTRODE (January 24, 1995)

Other clearances for product code ELE

  • K210228 — KLS Martin IPS Preprosthetic (July 8, 2022)
  • K862926 — SURGICAL VITEX (August 29, 1986)
  • K801208 — HOLLOW BASKET TITANIUM DENTAL IMPLANT (May 28, 1980)

FDA data resources