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510(k) K860583

DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315 by Dale Medical Products, Inc. — Product Code JAY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 1986
Date Received
February 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Support, Breathing Tube
Device Class
Class I
Regulation Number
868.5280
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)
  • K964399 — DALE ENDOTRACHEAL TUBE HOLDER 270/280 (January 28, 1997)
  • 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)

Other clearances for product code JAY

  • K944988 — CUSTOM MEDICAL SUSPENSION STRAP (January 27, 1995)
  • K873491 — BLOCK, BITE, INTUBATION (October 20, 1987)
  • K850924 — JEE FRAME (VENTILATOR CIRCUIT SUPPORT) (July 19, 1985)
  • K850309 — COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK (February 14, 1985)
  • K840844 — ENDO-SECURE (March 16, 1984)
  • K834265 — TRACH MATE (January 4, 1984)
  • K834089 — COMFIT (December 29, 1983)
  • K833374 — BITE-BLOCK (November 3, 1983)
  • K833361 — TUBE-TITLE (November 3, 1983)
  • K833332 — SCHULTZ ENDHOLD (October 31, 1983)