Cleared Traditional

SCALPEL HANDLE #7 SS 410 OR 420

K852735 · The Huxley Instrument Corp. · General & Plastic Surgery
Jul 1985
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K852735 is an FDA 510(k) clearance for the SCALPEL HANDLE #7 SS 410 OR 420, a Handle, Scalpel (Class I — General Controls, product code GDZ), submitted by The Huxley Instrument Corp. (Penn Yan, US). The FDA issued a Cleared decision on July 15, 1985, 19 days after receiving the submission on June 26, 1985. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K852735 FDA.gov
FDA Decision Cleared SESE
Date Received June 26, 1985
Decision Date July 15, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GDZ — Handle, Scalpel
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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