OXYGEN MOUTHGUARD— 510(k) K944049

Substantially Equivalent

Endovations, Inc.

FDA 510(k) clearance K944049 for OXYGEN MOUTHGUARD, Substantially Equivalent on 1994-10-11. Applicant: Endovations, Inc.. Device class: 1.

Clearance details

Applicant: Endovations, Inc.
Product code: Code MNK
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1994-08-18
Decision date: 1994-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Reading, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNK

K933537 — ENCOMPAS COMFORT BLOCK # 0B-101994-04-08
K931044 — OXY-BLOC1993-10-04
K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR1993-03-15
K914978 — OXYGUARD1992-01-10
K896691 — BITE BLOCK1990-02-12

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