SOFT TISSUE BIOPSY DEVICE— 510(k) K882013

Name: FDA 510(k) clearance K882013
Creator: U.S. Food and Drug Administration
Published: 1988-06-15

Substantially Equivalent

Ocean Medical Products, Ltd.

FDA 510(k) clearance K882013 for SOFT TISSUE BIOPSY DEVICE, Substantially Equivalent on 1988-06-15. Applicant: Ocean Medical Products, Ltd.. Device class: 1.

Clearance details

Applicant: Ocean Medical Products, Ltd.
Product code: Code DWO
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1988-05-13
Decision date: 1988-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wyoming, MI, 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.