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510(k) K812429

DALE COMBO TRACHEOSTOMY TUBE HOLDER by Dale Medical Products, Inc. — Product Code EQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
August 25, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Source, Carrier, Fiberoptic Light
Device Class
Class I
Regulation Number
874.4350
Review Panel
EN
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 EQH

  • K945876 — WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHT (December 4, 1995)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K951829 — COLD LIGHT SOURCE LOS 150 (July 10, 1995)
  • K932771 — BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCE (August 24, 1994)
  • K941661 — GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHT (August 23, 1994)
  • K941662 — GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT (July 20, 1994)
  • K934911 — SAPHIRE PLUS SURGICAL MIRROR (June 21, 1994)
  • K932131 — MID LABS TWIN ILLUMINATOR (April 1, 1994)
  • K930123 — ASPIRATING ENDO OCULAR PROBE (February 16, 1994)
  • K933145 — FIBEROPTIC LIGHTSOURCES AND CARRIERS (September 7, 1993)