APERTURE— 510(k) K895084

Substantially Equivalent

Custom Medical Products, Ltd.

FDA 510(k) clearance K895084 for APERTURE, Substantially Equivalent on 1989-10-27. Applicant: Custom Medical Products, Ltd.. Device class: 2.

Clearance details

Applicant: Custom Medical Products, Ltd.
Product code: Code IZS
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 1989-08-14
Decision date: 1989-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deer Park, NY, US

Download summary PDF View on FDA.gov ↗

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K930815 — ABDOMINAL / THORACIC PATIENT DRAPE1994-05-05
K931418 — SURGICAL DRAPE1994-05-05
K931455 — HEAD SHEET1994-05-05

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