BARRIER GYNECOLOGY PACK FABRIC 450— 510(k) K780856

Name: FDA 510(k) clearance K780856
Creator: U.S. Food and Drug Administration
Published: 1978-08-14

Substantially Equivalent

Surgikos, Inc.

FDA 510(k) clearance K780856 for BARRIER GYNECOLOGY PACK FABRIC 450, Substantially Equivalent on 1978-08-14. Applicant: Surgikos, Inc.. Device class: 2.

Clearance details

Applicant: Surgikos, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1978-05-24
Decision date: 1978-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.