V-808 ATOM TRANSCAPSULE— 510(k) K061071

Substantially Equivalent

Atom Medical, Inc.

FDA 510(k) clearance K061071 for V-808 ATOM TRANSCAPSULE, Substantially Equivalent on 2006-08-29. Applicant: Atom Medical, Inc.. Device class: 2.

Clearance details

Applicant: Atom Medical, Inc.
Product code: Code FPL
Device class: Class 2
Regulation: 21 CFR 880.5410
Advisory panel: General Hospital
Date received: 2006-04-17
Decision date: 2006-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ivyland, PA, US

Download summary PDF View on FDA.gov ↗

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