Cleared Traditional

ABIOMED PERIOTEMP(TM) PROBE

K885075 · Abiomed, Inc. · Dental
Feb 1989
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K885075 is an FDA 510(k) clearance for the ABIOMED PERIOTEMP(TM) PROBE, a Gauge, Depth, Instrument, Dental (Class I — General Controls, product code EIL), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on February 13, 1989, 67 days after receiving the submission on December 8, 1988. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K885075 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 1988
Decision Date February 13, 1989
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIL — Gauge, Depth, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565