FDA 510(k)

OCS-B

K-Number: K113246 · 2013-01-16

Decision Date2013-01-16

Product CodeNPM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OCS-B is the device name listed in this FDA 510(k) record. The listed applicant is Nibec Company, Limited. It received FDA 510(k) clearance on 2013-01-16 under 510(k) number K113246. The device is classified under product code NPM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OCS-B?

OCS-B is a medical device that received FDA 510(k) clearance on 2013-01-16. The listed applicant is Nibec Company, Limited. The 510(k) number is K113246.

When did OCS-B receive FDA 510(k) clearance?

OCS-B received FDA 510(k) clearance on 2013-01-16, under 510(k) number K113246.

Who is the listed applicant for OCS-B?

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

What is the FDA product code for OCS-B?

The FDA product code for OCS-B is NPM.

Related Devices (Code: NPM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254210REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)Hyundai Bioland Co., Ltd.K253723BOSSMedpark Co., Ltd.K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®Geistlich Pharma AG K251613SwissGraft XGeistlich Pharma AG K242510Geistlich Bio-Flow®Geistlich Pharma AG K240133Xenograft Bovine Bone ParticulateCollagen Solutions, LLC

Official Source

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