DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220— 510(k) K873311

Name: FDA 510(k) clearance K873311
Creator: U.S. Food and Drug Administration
Published: 1987-11-05

Substantially Equivalent

Dale Medical Products, Inc.

FDA 510(k) clearance K873311 for DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220, Substantially Equivalent on 1987-11-05. Applicant: Dale Medical Products, Inc.. Device class: 1.

Clearance details

Applicant: Dale Medical Products, Inc.
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1987-08-17
Decision date: 1987-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plainville, MA, US

Download summary PDF View on FDA.gov ↗

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K961693 — DALE GASTROSTOMY TUBE HOLDER1996-07-30
K951491 — DALE TRACHEOSTOMY TUBE HOLDER WITH TRACH MASK ATTACHMENT TABS1995-04-24

Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.