NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)— 510(k) K862364

Name: FDA 510(k) clearance K862364
Creator: U.S. Food and Drug Administration
Published: 1986-08-19

Substantially Equivalent for Some Indications

Swemed Laboratories, Inc.

FDA 510(k) clearance K862364 for NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS), Substantially Equivalent for Some Indications on 1986-08-19. Applicant: Swemed Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Swemed Laboratories, Inc.
Product code: Code HEM
Device class: Class 2
Regulation: 21 CFR 884.2225
Advisory panel: Obstetrics/Gynecology
Date received: 1986-06-24
Decision date: 1986-08-19
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Sweden, SE

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