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FDA 510(k)

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN

K-Number: K122561 · 2012-11-27

ApplicantCeremed , Inc.
Decision Date2012-11-27
Product CodeKHJ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN is the device name listed in this FDA 510(k) record. The listed applicant is Ceremed , Inc.. It received FDA 510(k) clearance on 2012-11-27 under 510(k) number K122561. The device is classified under product code KHJ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN?

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN is a medical device that received FDA 510(k) clearance on 2012-11-27. The listed applicant is Ceremed , Inc.. The 510(k) number is K122561.

When did ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN receive FDA 510(k) clearance?

ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN received FDA 510(k) clearance on 2012-11-27, under 510(k) number K122561.

Who is the listed applicant for ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN?

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

What is the FDA product code for ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN?

The FDA product code for ADAPTAIN FASTWRAP, ENVELOCK, GRAFTAIN is KHJ.

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Other records listing Ceremed , 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.

K161446Biopor Porous Polyethylene ImplantsK160988Biopor, AOC Porous Polyethylene, CereporK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAIK120220ADAPTAIN SOLUBLE IMPLANT MATERIALK103047CERETENE SOLUBLE IMPLANT MATERIALK102071OSTENE CT, AOC CT, OSTEOTENE, CERETENE

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Related Devices (Code: KHJ)

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.

K260266Tympendi™ (810)Grace Medical, Inc.K232646Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6); Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.6-0.9)Cook Biotech IncorporatedK161000Biodesign Otologic Repair GraftCook Biotech IncorporatedK132198ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAICeremed , Inc.K121360BIODESIGN ENT REPAIR GRAFTCook Biotech IncorpratedK120220ADAPTAIN SOLUBLE IMPLANT MATERIALCeremed , 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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