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FDA 510(k)

MAGNETIC PORT SILICONE TISSUE EXPANDER

K-Number: K982067 · 1998-07-13

ApplicantSpecialty Surgical Products, Inc.
Decision Date1998-07-13
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

MAGNETIC PORT SILICONE 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 1998-07-13 under 510(k) number K982067. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNETIC PORT SILICONE TISSUE EXPANDER?

MAGNETIC PORT SILICONE TISSUE EXPANDER is a medical device that received FDA 510(k) clearance on 1998-07-13. The listed applicant is Specialty Surgical Products, Inc.. The 510(k) number is K982067.

When did MAGNETIC PORT SILICONE TISSUE EXPANDER receive FDA 510(k) clearance?

MAGNETIC PORT SILICONE TISSUE EXPANDER received FDA 510(k) clearance on 1998-07-13, under 510(k) number K982067.

Who is the listed applicant for MAGNETIC PORT SILICONE 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 MAGNETIC PORT SILICONE TISSUE EXPANDER?

The FDA product code for MAGNETIC PORT SILICONE 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 COVERK974653SILICONE ELASTOMER SHEETINGK974654SILICONE BLOCKS

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Related Devices (Code: LCJ)

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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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