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FDA 510(k)

RELINE-IT MODEL RELINE-IT

K-Number: K101771 · 2010-09-20

ApplicantMajestic Drug Co., Inc.
Decision Date2010-09-20
Product CodeEBP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RELINE-IT MODEL RELINE-IT is the device name listed in this FDA 510(k) record. The listed applicant is Majestic Drug Co., Inc.. It received FDA 510(k) clearance on 2010-09-20 under 510(k) number K101771. The device is classified under product code EBP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RELINE-IT MODEL RELINE-IT?

RELINE-IT MODEL RELINE-IT is a medical device that received FDA 510(k) clearance on 2010-09-20. The listed applicant is Majestic Drug Co., Inc.. The 510(k) number is K101771.

When did RELINE-IT MODEL RELINE-IT receive FDA 510(k) clearance?

RELINE-IT MODEL RELINE-IT received FDA 510(k) clearance on 2010-09-20, under 510(k) number K101771.

Who is the listed applicant for RELINE-IT MODEL RELINE-IT?

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

What is the FDA product code for RELINE-IT MODEL RELINE-IT?

The FDA product code for RELINE-IT MODEL RELINE-IT is EBP.

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Other records listing Majestic Drug Co., 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.

K964773DENTEMP ONE STEPK821581DEN TEMP

Related Devices (Code: EBP)

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.

K121318PROSOFTPerma LaboratoriesK790589DENTURE-TIGHTDen-Mat Corp.

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.

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