REUSABLE LIQUIDPROOF BOOTIE— 510(k) K925815

Name: FDA 510(k) clearance K925815
Creator: U.S. Food and Drug Administration
Published: 1993-07-09

Substantially Equivalent

Amsco Sterile Recoveries, Inc.

FDA 510(k) clearance K925815 for REUSABLE LIQUIDPROOF BOOTIE, Substantially Equivalent on 1993-07-09. Applicant: Amsco Sterile Recoveries, Inc.. Device class: 1.

Clearance details

Applicant: Amsco Sterile Recoveries, Inc.
Product code: Code FXP
Device class: Class 1
Regulation: 21 CFR 878.4040
Advisory panel: General, Plastic Surgery
Date received: 1992-11-17
Decision date: 1993-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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K931146 — SURGICAL DRAPES, MODIFICATION1994-06-13
K931144 — STERILE SURGEON'S GOWN, MODIFICATION1994-06-10
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