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510(k) K914245

DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600) by Dale Medical Products, Inc. — Product Code KGX

K914245 is an FDA 510(k) premarket notification submitted by Dale Medical Products, Inc. for the device "DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)". The FDA issued a decision of Substantially Equivalent on December 9, 1991. The device falls under product code KGX (Tape And Bandage, Adhesive), a Class I device regulated under 21 CFR 880.5240. Dale Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 1991
Date Received
September 23, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tape And Bandage, Adhesive
Device Class
Class I
Regulation Number
880.5240
Review Panel
SU
Submission Type

Other clearances by Dale Medical Products, Inc.

  • K082241 — THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 (October 30, 2008)
  • 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)
  • 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 KGX

  • K001240 — SERAGARD INJECTION PATCH (June 21, 2000)
  • K983368 — CARE BAND ANTIBACTERIAL BANDAGES (February 17, 1999)
  • K972914 — SYVEK PATCH (December 22, 1997)
  • K943314 — ADHESIVE BANDAGES WITH OTC DRUG (January 17, 1996)
  • K952606 — TARGETT PATCH (December 21, 1995)
  • K954007 — PARALLEL (November 22, 1995)
  • K944587 — DERMIVIEW HYPOALLERGENIC CLEAR TAPE (October 30, 1995)
  • K944588 — STERILE PLASTIC DRESSING (November 7, 1994)
  • K941788 — BAND-AID BRAND ADHESIVE BANDAGES, SPORT STRIP (October 3, 1994)
  • K940536 — BAND-AID(TM) BRAND ADHESIVE BANDAGE (October 3, 1994)

FDA data resources