Cleared Traditional

STERILE IMPERVIOUS ORTHOPEDIC STOCKIN

K792357 · Alba-Waldensian, Inc. · General Hospital
Dec 1979
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K792357 is an FDA 510(k) clearance for the STERILE IMPERVIOUS ORTHOPEDIC STOCKIN, a Drape, Surgical (Class II — Special Controls, product code KKX), submitted by Alba-Waldensian, Inc. (Walker, US). The FDA issued a Cleared decision on December 18, 1979, 27 days after receiving the submission on November 21, 1979. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K792357 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 1979
Decision Date December 18, 1979
Days to Decision 27 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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