Cleared Traditional

STRAITH CHIN IMPLANTS

K801073 · Surgical Technology Laboratories, Inc. · General & Plastic Surgery
May 1980
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K801073 is an FDA 510(k) clearance for the STRAITH CHIN IMPLANTS, a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP), submitted by Surgical Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 20, 1980, 14 days after receiving the submission on May 6, 1980. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K801073 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1980
Decision Date May 20, 1980
Days to Decision 14 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FWP — Prosthesis, Chin, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3550

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