NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE— 510(k) K862365

Name: FDA 510(k) clearance K862365
Creator: U.S. Food and Drug Administration
Published: 1986-07-07

Substantially Equivalent

Swemed Laboratories, Inc.

FDA 510(k) clearance K862365 for NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE, Substantially Equivalent on 1986-07-07. Applicant: Swemed Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Swemed Laboratories, Inc.
Product code: Code HIO
Device class: Class 1
Regulation: 21 CFR 884.1550
Advisory panel: Obstetrics/Gynecology
Date received: 1986-06-24
Decision date: 1986-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sweden, SE

Download summary PDF View on FDA.gov ↗

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