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510(k) K781937

PROTHESIS, METACARPAL by Cutter Laboratories, Inc.

K781937 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "PROTHESIS, METACARPAL". The FDA issued a decision of Substantially Equivalent on January 17, 1979. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1979
Date Received
November 20, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)

FDA data resources