BITE BLOCK— 510(k) K896691

Substantially Equivalent

Endoscopix

FDA 510(k) clearance K896691 for BITE BLOCK, Substantially Equivalent on 1990-02-12. Applicant: Endoscopix. Device class: 1.

Clearance details

Applicant: Endoscopix
Product code: Code MNK
Device class: Class 1
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1989-11-28
Decision date: 1990-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, CA, 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
K931044 — OXY-BLOC1993-10-04
K924764 — OVERTUBE FOR ENDSCOPIC LIGATOR1993-03-15
K914978 — OXYGUARD1992-01-10

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