ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1— 510(k) K040641

Name: FDA 510(k) clearance K040641
Creator: U.S. Food and Drug Administration
Published: 2004-05-05

Substantially Equivalent

Epicor Medical, Inc.

FDA 510(k) clearance K040641 for ULTRACINCH ABLATION DEVICE, ULTRACINCH ACCESSORY PACK, MODELS UC-8, UC-9, UC-10, UC-11, UC-12, UC-13, UC-14, UC-ACC-1, Substantially Equivalent on 2004-05-05. Applicant: Epicor Medical, Inc.. Device class: 2.

Clearance details

Applicant: Epicor Medical, Inc.
Product code: Code NTB
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2004-03-10
Decision date: 2004-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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