Cleared Traditional

K791070 - ACCU-SORB STERILE STOCKINETTES (FDA 510(k) Clearance)

Jun 1979
Decision
8d
Days
Class 2
Risk

K791070 is an FDA 510(k) clearance for the ACCU-SORB STERILE STOCKINETTES. This device is classified as a Drape, Surgical (Class II - Special Controls, product code KKX).

Submitted by Medline Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1979, 8 days after receiving the submission on June 12, 1979.

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

Submission Details

510(k) Number K791070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date June 20, 1979
Days to Decision 8 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