CANNULAE, PLASTIC DISPOSABLE NASAL— 510(k) K760218

Name: FDA 510(k) clearance K760218
Creator: U.S. Food and Drug Administration
Published: 1976-08-03

Substantially Equivalent

Manner Medical Products

FDA 510(k) clearance K760218 for CANNULAE, PLASTIC DISPOSABLE NASAL, Substantially Equivalent on 1976-08-03. Applicant: Manner Medical Products. Device class: 1.

Clearance details

Applicant: Manner Medical Products
Product code: Code CAT
Device class: Class 1
Regulation: 21 CFR 868.5340
Advisory panel: Anesthesiology
Date received: 1976-07-12
Decision date: 1976-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K921496 — SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED1992-08-14
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More clearances from Manner Medical Products

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K760219 — MASKA, OXYGEN VINYL D-SP. SINGLE USE1976-08-03
K760220 — TUBING, SINGLE USE OXYGEN SUPPLY1976-08-03
K760221 — I.P.P.B., DIS. W/MANIFOLD/NEBULIZER1976-08-03

Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.