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FDA 510(k)

PERIOPHIL B-TCP

K-Number: K093871 · 2010-04-22

ApplicantCytophil, Inc.
Decision Date2010-04-22
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERIOPHIL B-TCP is the device name listed in this FDA 510(k) record. The listed applicant is Cytophil, Inc.. It received FDA 510(k) clearance on 2010-04-22 under 510(k) number K093871. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIOPHIL B-TCP?

PERIOPHIL B-TCP is a medical device that received FDA 510(k) clearance on 2010-04-22. The listed applicant is Cytophil, Inc.. The 510(k) number is K093871.

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

PERIOPHIL B-TCP received FDA 510(k) clearance on 2010-04-22, under 510(k) number K093871.

Who is the listed applicant for PERIOPHIL B-TCP?

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

What is the FDA product code for PERIOPHIL B-TCP?

The FDA product code for PERIOPHIL B-TCP is LYC.

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Other records listing Cytophil, Inc. as applicant

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.

K121795CALCIUM HYDROXYLAPATITE VOCAL FOLD IMPLANTK102937OSTEOPHIL BETA-TCPK092788PERIOPHIL BIPHASICK081815VOCALIS GELK081816VOCALIS AND VOCALIS SMK072219CYTOPHIL TISSUE MARKER

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Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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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