Cleared Traditional

ODONTIT AUTOGENOUS BONE COLLECTION DEVICE

K971036 · Interpore Intl. · General & Plastic Surgery
Jun 1997
Decision
75d
Days
Class 1
Risk

About This 510(k) Submission

K971036 is an FDA 510(k) clearance for the ODONTIT AUTOGENOUS BONE COLLECTION DEVICE, a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I — General Controls, product code GCY), submitted by Interpore Intl. (Irvine, US). The FDA issued a Cleared decision on June 3, 1997, 75 days after receiving the submission on March 20, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.

Submission Details

510(k) Number K971036 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 1997
Decision Date June 03, 1997
Days to Decision 75 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4680

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