MASTER & FRANK SURGICAL DRAPES (STERILE)— 510(k) K020393

Name: FDA 510(k) clearance K020393
Creator: U.S. Food and Drug Administration
Published: 2002-05-03

Substantially Equivalent

Master & Frank Enterprses Co., Ltd.

FDA 510(k) clearance K020393 for MASTER & FRANK SURGICAL DRAPES (STERILE), Substantially Equivalent on 2002-05-03. Applicant: Master & Frank Enterprses Co., Ltd.. Device class: 2.

Clearance details

Applicant: Master & Frank Enterprses Co., Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2002-02-06
Decision date: 2002-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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Recalls naming K020393

K-number listed on FDA's recall record

Z-1889-2026 — Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061JClass II·Ongoing·Medline Industries, LP·20260227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020393.

Data sourced from openFDA. This site is unofficial and independent of the FDA.