Cleared Traditional

K882724 - MICROTEK PROBE DRAPE
(FDA 510(k) Clearance)

Aug 1988
Decision
33d
Days
Class 2
Risk

K882724 is an FDA 510(k) clearance for the MICROTEK PROBE DRAPE. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).

Submitted by Microbio-Medics, Inc. (Columbus, US). The FDA issued a Cleared decision on August 3, 1988, 33 days after receiving the submission on July 1, 1988.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K882724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1988
Decision Date August 03, 1988
Days to Decision 33 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code KKX — Drape, Surgical
Device Class Class II - Special Controls
CFR Regulation 21 CFR 878.4370

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