Cleared Traditional

K890314 - PROTECTOR (SURGICAL INSTRUMENT)
(FDA 510(k) Clearance)

Feb 1989
Decision
35d
Days
Class 2
Risk

K890314 is an FDA 510(k) clearance for the PROTECTOR (SURGICAL INSTRUMENT). This device is classified as a Container, Sharps (Class II - Special Controls, product code MMK).

Submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on February 27, 1989, 35 days after receiving the submission on January 23, 1989.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5570.

Submission Details

510(k) Number K890314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date February 27, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code MMK — Container, Sharps
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.5570

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