Cleared Special

NASAL DORSAL SERIES

K983755 · Surgical Technology Laboratories, Inc. · General & Plastic Surgery
Nov 1998
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K983755 is an FDA 510(k) clearance for the NASAL DORSAL SERIES, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Surgical Technology Laboratories, Inc. (Cleveland, US). The FDA issued a Cleared decision on November 20, 1998, 29 days after receiving the submission on October 22, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K983755 FDA.gov
FDA Decision Cleared SESE
Date Received October 22, 1998
Decision Date November 20, 1998
Days to Decision 29 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code FZE — Prosthesis, Nose, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3680

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