Cleared Traditional

STRAITH NASAL IMPLANT

K801074 · Surgical Technology Laboratories, Inc. · General & Plastic Surgery
Jun 1980
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K801074 is an FDA 510(k) clearance for the STRAITH NASAL IMPLANT, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Surgical Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 17, 1980, 42 days after receiving the submission on May 6, 1980. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K801074 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1980
Decision Date June 17, 1980
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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

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