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510(k) K961693

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

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

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  • 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)