OXY-BLOC— 510(k) K931044

Substantially Equivalent

Gi Supply

FDA 510(k) clearance K931044 for OXY-BLOC, Substantially Equivalent on 1993-10-04. Applicant: Gi Supply. Device class: 1.

Clearance details

Applicant: Gi Supply
Product code: Code MNK
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1993-03-01
Decision date: 1993-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camp Hill, PA, US

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
K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR1993-03-15
K914978 — OXYGUARD1992-01-10
K896691 — BITE BLOCK1990-02-12

More clearances from Gi Supply

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K031360 — GI SUPPLY BILIARY STENT2003-09-24
K012411 — HP-ONE2001-09-25
K970186 — GI SUPPLY PARACENTESIS PUMP1997-02-14
K970187 — RUNYON LARGE VOLUME PARACENTESIS KIT1997-02-14

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