ABIODENT PERIOTEMP(R) SYSTEM— 510(k) K911643

Substantially Equivalent

Abiomed, Inc.

FDA 510(k) clearance K911643 for ABIODENT PERIOTEMP(R) SYSTEM, Substantially Equivalent on 1991-07-09. Applicant: Abiomed, Inc.. Device class: 1.

Clearance details

Applicant: Abiomed, Inc.
Product code: Code EIL
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 1991-04-12
Decision date: 1991-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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