THE EXPANDACELL SINUS PACK— 510(k) K935724

Substantially Equivalent

Denver Splint Co.

FDA 510(k) clearance K935724 for THE EXPANDACELL SINUS PACK, Substantially Equivalent on 1994-05-12. Applicant: Denver Splint Co.. Device class: 1.

Clearance details

Applicant: Denver Splint Co.
Product code: Code EMX
Device class: Class 1
Regulation: 21 CFR 874.4100
Advisory panel: Ear, Nose, Throat
Date received: 1993-12-01
Decision date: 1994-05-12
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
K940133 — THE EXPANDACELL EAR PACK1994-05-23
K922062 — THE DENVER CAUTERY1993-01-12

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