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FDA 510(k)

SILICONE TISSUE/INFLATABLE TISSUE EXPANDER

K-Number: K974209 · 1998-02-06

ApplicantSpecialty Surgical Products, Inc.
Decision Date1998-02-06
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

SILICONE TISSUE/INFLATABLE TISSUE EXPANDER is the device name listed in this FDA 510(k) record. The listed applicant is Specialty Surgical Products, Inc.. It received FDA 510(k) clearance on 1998-02-06 under 510(k) number K974209. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE TISSUE/INFLATABLE TISSUE EXPANDER?

SILICONE TISSUE/INFLATABLE TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1998-02-06. The listed applicant is Specialty Surgical Products, Inc.. The 510(k) number is K974209.

When did SILICONE TISSUE/INFLATABLE TISSUE EXPANDER receive FDA 510(k) clearance?

SILICONE TISSUE/INFLATABLE TISSUE EXPANDER received FDA 510(k) clearance on 1998-02-06, under 510(k) number K974209.

Who is the listed applicant for SILICONE TISSUE/INFLATABLE TISSUE EXPANDER?

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

What is the FDA product code for SILICONE TISSUE/INFLATABLE TISSUE EXPANDER?

The FDA product code for SILICONE TISSUE/INFLATABLE TISSUE EXPANDER is LCJ.

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Other records listing Specialty Surgical Products, 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.

K984106MAMMARY SIZER, MAMMARY PROTHESIS SIZERK983015VIRILIS PENILE PROSTHESISK982258MAMMARY SIZERK982065STERILE SILICONE EXTERNAL WOUND COVERK982067MAGNETIC PORT SILICONE TISSUE EXPANDERK974653SILICONE ELASTOMER SHEETING

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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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