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510(k) K964399

DALE ENDOTRACHEAL TUBE HOLDER 270/280 by Dale Medical Products, Inc. — Product Code CBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1997
Date Received
November 4, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Fixation, Tracheal Tube
Device Class
Class I
Regulation Number
868.5770
Review Panel
AN
Submission Type

Other clearances by Dale Medical Products, Inc.

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  • K994300 — NASOGASTRIC TUBE HOLDER, MODEL 160 (February 10, 2000)
  • K961693 — DALE GASTROSTOMY TUBE HOLDER (July 30, 1996)
  • K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (April 24, 1995)
  • K914245 — DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) (December 9, 1991)
  • K905231 — DALE VENTILATOR TUBING SUPPORT FOR TRACH. VENT. (January 14, 1991)
  • K894586 — DALE I.V. IDENTIFIER; PRODUCT #1125 (August 15, 1989)
  • K873311 — DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220 (November 5, 1987)
  • K864897 — DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 (January 12, 1987)
  • K860583 — DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 (February 21, 1986)

Other clearances for product code CBH

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  • K942529 — HCI TUBE STABILIZER (June 14, 1995)
  • K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS (April 24, 1995)
  • K950930 — TRACHE-TITE (March 22, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)
  • K942395 — ENDOTRACHEAL TUBE HOLDER (June 30, 1994)
  • K934288 — HOLDE.T. ENDOTRACHEAL TUBE STABILIZATION BAR (June 9, 1994)
  • K942016 — TRACH TIE, VENTILATOR TUBING HOLDER (May 24, 1994)
  • K941384 — TRAKEEZ (April 19, 1994)
  • K940448 — NETOH ENDOTRACHEAL TUBE HOLDER (February 22, 1994)