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510(k) K792250

CUTTER POINTS by Cutter Laboratories, Inc. — Product Code EHL

K792250 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "CUTTER POINTS". The FDA issued a decision of Substantially Equivalent on January 23, 1980. The device falls under product code EHL (Point, Abrasive), a Class I device regulated under 21 CFR 872.6010. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1980
Date Received
November 8, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Point, Abrasive
Device Class
Class I
Regulation Number
872.6010
Review Panel
DE
Submission Type

Other clearances by Cutter Laboratories, Inc.

  • K861315 — HYPERBARIC PENETRATION EXTENSION SET (May 21, 1986)
  • K854106 — BAYSILEX (March 17, 1986)
  • K842324 — PERFOURM (November 9, 1984)
  • K834106 — INTRAVENOUS INFUSION CONTROLLER (May 30, 1984)
  • K832237 — ORTHOPEDIC CASTING TAPE MAXCAST (August 16, 1983)
  • K823214 — DOSIMETRIC RELEASE PROGRAM - ADMIN. SET (January 12, 1983)
  • K821326 — CUTTER BOND POLYCARBOXYLATE CEMENT (May 28, 1982)
  • K813532 — CUTTERBOND ZINC PHOSPHATE CEMENT (March 2, 1982)
  • K802105 — C-BLADE (September 16, 1980)
  • K802104 — C-SPLINT (September 16, 1980)

Other clearances for product code EHL

  • K780811 — DENTAL ABRASIVE DEVICE (June 22, 1978)
  • K780377 — PINIDENTOFLEX DENTAL POLISHER (March 14, 1978)
  • K780376 — MINIDENTOFLEX NEW POLISHING SYSTEM (March 14, 1978)

FDA data resources