OXYGUARD— 510(k) K914978

Substantially Equivalent

Stantex Pty , Ltd.

FDA 510(k) clearance K914978 for OXYGUARD, Substantially Equivalent on 1992-01-10. Applicant: Stantex Pty , Ltd.. Device class: 1.

Clearance details

Applicant: Stantex Pty , Ltd.
Product code: Code MNK
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1991-11-06
Decision date: 1992-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sydney, New South Wales, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNK

K944049 — OXYGEN MOUTHGUARD1994-10-11
K933537 — ENCOMPAS COMFORT BLOCK # 0B-101994-04-08
K931044 — OXY-BLOC1993-10-04
K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR1993-03-15
K896691 — BITE BLOCK1990-02-12

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