Cleared Traditional

K801819 - SURGICAL INSTRUMENTS
(FDA 510(k) Clearance)

K801819 · Robert I. Chien & Assoc., Inc. · General & Plastic Surgery device

Aug 1980

Decision

20d

Days

Class 1

Risk

K801819 is an FDA 510(k) clearance for the SURGICAL INSTRUMENTS. This device is classified as a Clamp (Class I - General Controls, product code HXD).

Submitted by Robert I. Chien & Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980, 20 days after receiving the submission on July 31, 1980.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K801819 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 31, 1980
Decision Date	August 20, 1980
Days to Decision	20 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—