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FDA 510(k)

RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)

K-Number: K884250 · 1989-06-12

ApplicantMentor Corp.
Decision Date1989-06-12
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Corp.. It received FDA 510(k) clearance on 1989-06-12 under 510(k) number K884250. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)?

RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) is a medical device that received FDA 510(k) clearance on 1989-06-12. The listed applicant is Mentor Corp.. The 510(k) number is K884250.

When did RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) receive FDA 510(k) clearance?

RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) received FDA 510(k) clearance on 1989-06-12, under 510(k) number K884250.

Who is the listed applicant for RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)?

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

What is the FDA product code for RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.)?

The FDA product code for RADOVAN TISSUE EXPANDER (OPTION INTEGRAL INJECT.) is LCJ.

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Other records listing Mentor 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.

K130813MENTOR CPX 4 BREAST TISSUE EXPANDERS AND MENTOR CPX 4 WITH SUTURE TABS BREAST TISSUE EXPANDERSK053414MENTOR NOVASILK MESHK050008MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETERK042851MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KITK040959MENTOR GENESIS PENILE PROSTHESISK031767MENTOR OBTAPE TRANS-OBTURATOR TAPE

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Related Devices (Code: LCJ)

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.

K254126Natrelle 133S Tissue ExpandersAbbVieK242963MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture TabsMentor Worldwide, LLCK243836Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK241918MENTOR™ CPX™4 PLUS Enhance Breast Tissue ExpanderMentor Worldwide, LLCK211676Motiva Flora SmoothSilk Tissue ExpanderMotiva USA, LLCK214124AlloX2 Pro Tissue ExpandersSientra, 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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