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510(k) K961693

DALE GASTROSTOMY TUBE HOLDER by Dale Medical Products, Inc. — Product Code PLI

K961693 is an FDA 510(k) premarket notification submitted by Dale Medical Products, Inc. for the device "DALE GASTROSTOMY TUBE HOLDER". The FDA issued a decision of Substantially Equivalent on July 30, 1996. The device falls under product code PLI (Gastrointestional Tube Holder), a Class II device regulated under 21 CFR 876.5980. Dale Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1996
Date Received
May 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gastrointestional Tube Holder
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Intended to support, secure, and hold gastrointestinal tubes

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)
  • 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)

FDA data resources