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510(k) K811995

FORAMATRON APICAL FORAMEN LOCATOR by Parker Laboratories, Inc.

K811995 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "FORAMATRON APICAL FORAMEN LOCATOR". The FDA issued a decision of Substantially Equivalent on September 21, 1981. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1981
Date Received
July 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Parker Laboratories, Inc.

  • K233965 — UltraDrape UGPIV Barrier and Securement (34-15) (August 15, 2024)
  • K953673 — ECLIPSE PROBE COVER (March 14, 1996)
  • K921695 — ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERS (February 23, 1995)
  • K864556 — AQUALUBE(TM) (December 1, 1986)
  • K861239 — ACRYLIC SOLDER (April 17, 1986)
  • K855167 — DYNA SYSTEM (March 4, 1986)
  • K851895 — POLYGEL ULTRASOUND GEL (September 27, 1985)
  • K852956 — CONTACT CONDUCTIVE ADHESIVE GEL COMPOSITION (August 9, 1985)
  • K841400 — NEURO PULSE (June 15, 1984)
  • K840548 — RESIL (April 17, 1984)

FDA data resources