THE EXPANDACELL EAR PACK— 510(k) K940133

Substantially Equivalent

Denver Splint Co.

FDA 510(k) clearance K940133 for THE EXPANDACELL EAR PACK, Substantially Equivalent on 1994-05-23. Applicant: Denver Splint Co.. Device class: 1.

Clearance details

Applicant: Denver Splint Co.
Product code: Code LRD
Device class: Class 1
Regulation: 21 CFR 874.5220
Advisory panel: Ear, Nose, Throat
Date received: 1994-01-03
Decision date: 1994-05-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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More clearances from Denver Splint Co.

K940798 — SHIPPERT PRESSURE BANDAGE1994-09-28
K935724 — THE EXPANDACELL SINUS PACK1994-05-12
K922062 — THE DENVER CAUTERY1993-01-12

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