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FDA 510(k)

SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY

K-Number: K113728 · 2012-11-15

ApplicantHans Biomed Corp.
Decision Date2012-11-15
Product CodeMBP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY is the device name listed in this FDA 510(k) record. The listed applicant is Hans Biomed Corp.. It received FDA 510(k) clearance on 2012-11-15 under 510(k) number K113728. The device is classified under product code MBP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY?

SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY is a medical device that received FDA 510(k) clearance on 2012-11-15. The listed applicant is Hans Biomed Corp.. The 510(k) number is K113728.

When did SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY receive FDA 510(k) clearance?

SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY received FDA 510(k) clearance on 2012-11-15, under 510(k) number K113728.

Who is the listed applicant for SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY?

The FDA 510(k) record lists Hans Biomed Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY?

The FDA product code for SURFUSE GEL AND PUTTY, EXFUSE GEL AND PUTTY is MBP.

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Other records listing Hans Biomed Corp. 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.

K152077MaxiGenK151271BellaFuse

Related Devices (Code: MBP)

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.

K242799PliaFX FloLifenet HealthK130703VIVORTE BVFVivorte, Inc.K130498OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTYBacterin International, Inc.K122513CLEARED UNDER GRAFTON II EDBMMedtronic Sofamor Danek, Inc.K103742ACCELL EVO3 (FORMERLY ACCELL A2I)Integra Life SciencesK091193ACCELL EVO3CIsotis Orthobiologics, Inc.

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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