SURGICAL DRAPES— 510(k) K011422

Substantially Equivalent

Advance Medical Designs, Inc.

FDA 510(k) clearance K011422 for SURGICAL DRAPES, Substantially Equivalent on 2001-07-10. Applicant: Advance Medical Designs, Inc.. Device class: 2.

Clearance details

Applicant: Advance Medical Designs, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2001-05-09
Decision date: 2001-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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K011265 — ULTRASOUND TRANSDUCER COVER2001-10-30
K012168 — ADVANCE MEDICAL DESIGNS FLUID POUCH2001-09-18

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