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510(k) K863752

VALTRAC (BAR) REMOVER DEVICE by Davis & Geck, Inc. — Product Code EMF

K863752 is an FDA 510(k) premarket notification submitted by Davis & Geck, Inc. for the device "VALTRAC (BAR) REMOVER DEVICE". The FDA issued a decision of Substantially Equivalent on October 24, 1986. The device falls under product code EMF (Knife, Surgical), a Class I device regulated under 21 CFR 878.4800. Davis & Geck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1986
Date Received
September 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Davis & Geck, Inc.

  • K982853 — SILK SUTURE (April 30, 1999)
  • K981582 — SURGILON, DERMALON, & OPHTHALON (July 13, 1998)
  • K974015 — ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QU (May 18, 1998)
  • K980610 — DEXON RAPID (DEXON R) (May 18, 1998)
  • K980062 — MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE (March 20, 1998)
  • K973409 — KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS (February 27, 1998)
  • K970857 — ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL AR (November 5, 1997)
  • K972139 — ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOP (September 3, 1997)
  • K972566 — DEXON VIOLET (August 14, 1997)
  • K962971 — POLYPROPYLENE MESH (VARIOUS SIZES) (September 16, 1996)

Other clearances for product code EMF

  • K080133 — MOUNTABLE ENDOSCOPIC BLADE (March 13, 2008)
  • K982142 — MOUNTABLE ENDOSCOPIC KNIFE (December 30, 1998)
  • K890214 — MICROSURGERY RAZOR BLADE HOLDER (January 27, 1989)
  • K890217 — MICROSURGICAL KNIVES (January 27, 1989)
  • K890215 — MICROSURGICAL SCARIFIER (January 27, 1989)
  • K880094 — VAN-TEC ENDOPYELOTOMY KNIFE (February 29, 1988)
  • K863549 — REUSABLE/DISPOSABLE AUTOPSY KNIFE SET (September 30, 1986)
  • K861947 — SURGICAL KNIFE (June 6, 1986)
  • K854891 — KNIFE (May 2, 1986)
  • K851784 — 27-210 PLASTER KNIFE (REINER) (June 20, 1985)

FDA data resources