RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY— 510(k) K955679

Name: FDA 510(k) clearance K955679
Creator: U.S. Food and Drug Administration
Published: 1996-03-12

Substantially Equivalent

Contour Fabricators of Florida, Inc.

FDA 510(k) clearance K955679 for RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY, Substantially Equivalent on 1996-03-12. Applicant: Contour Fabricators of Florida, Inc.. Device class: 1.

Clearance details

Applicant: Contour Fabricators of Florida, Inc.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1995-12-14
Decision date: 1996-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harobor, FL, US

Download summary PDF View on FDA.gov ↗

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K921738 — SONO-VU US(TM), MODIFICATION1992-04-27
K915863 — MEGA AMNIOCENTESIS KIT1992-03-30

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K955687 — RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY1996-06-03
K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY1996-05-15
K955684 — RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY1996-05-02

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