KSEA SCALP BLOOD COLLECTION SET— 510(k) K954982

Name: FDA 510(k) clearance K954982
Creator: U.S. Food and Drug Administration
Published: 1996-07-17

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K954982 for KSEA SCALP BLOOD COLLECTION SET, Substantially Equivalent on 1996-07-17. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HGK
Device class: Class 2
Regulation: 21 CFR 884.1660
Advisory panel: Obstetrics/Gynecology
Date received: 1995-10-31
Decision date: 1996-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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