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FDA 510(k)

OS-1 OCCLUSION SYSTEM - 1

K-Number: K894839 · 1989-10-24

ApplicantMedical, Inc.
Decision Date1989-10-24
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OS-1 OCCLUSION SYSTEM - 1 is the device name listed in this FDA 510(k) record. The listed applicant is Medical, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K894839. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OS-1 OCCLUSION SYSTEM - 1?

OS-1 OCCLUSION SYSTEM - 1 is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Medical, Inc.. The 510(k) number is K894839.

When did OS-1 OCCLUSION SYSTEM - 1 receive FDA 510(k) clearance?

OS-1 OCCLUSION SYSTEM - 1 received FDA 510(k) clearance on 1989-10-24, under 510(k) number K894839.

Who is the listed applicant for OS-1 OCCLUSION SYSTEM - 1?

The FDA 510(k) record lists Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OS-1 OCCLUSION SYSTEM - 1?

The FDA product code for OS-1 OCCLUSION SYSTEM - 1 is BZC.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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