OXYGEN MASKS 81420, 81421, 81471 & 81461— 510(k) K913383

Name: FDA 510(k) clearance K913383
Creator: U.S. Food and Drug Administration
Published: 1991-10-18

Substantially Equivalent

Specialty Packaging Producs, Inc.

FDA 510(k) clearance K913383 for OXYGEN MASKS 81420, 81421, 81471 & 81461, Substantially Equivalent on 1991-10-18. Applicant: Specialty Packaging Producs, Inc.. Device class: 1.

Clearance details

Applicant: Specialty Packaging Producs, Inc.
Product code: Code BYG
Device class: Class 1
Regulation: 21 CFR 868.5580
Advisory panel: Anesthesiology
Date received: 1991-07-29
Decision date: 1991-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Paso, TX, US

Download summary PDF View on FDA.gov ↗

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K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS1995-09-15

More clearances from Specialty Packaging Producs, Inc.

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K922492 — SPECIALTY PACKAGING PROD BACTERIAL/VIRAL FILTER1992-08-24
K913163 — NON REBREATHING VALVE1992-02-03
K913422 — OXYGEN TUBING, 815031992-01-30
K913164 — NON REBREATHING MASK1992-01-15
K913216 — TRACH T ADAPTER1992-01-15

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