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FDA 510(k)

SILICONE ELASTOMER SHEETING

K-Number: K974653 · 1998-03-13

ApplicantSpecialty Surgical Products, Inc.
Decision Date1998-03-13
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILICONE ELASTOMER SHEETING 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 1998-03-13 under 510(k) number K974653. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE ELASTOMER SHEETING?

SILICONE ELASTOMER SHEETING is a medical device that received FDA 510(k) clearance on 1998-03-13. The listed applicant is Specialty Surgical Products, Inc.. The 510(k) number is K974653.

When did SILICONE ELASTOMER SHEETING receive FDA 510(k) clearance?

SILICONE ELASTOMER SHEETING received FDA 510(k) clearance on 1998-03-13, under 510(k) number K974653.

Who is the listed applicant for SILICONE ELASTOMER SHEETING?

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 ELASTOMER SHEETING?

The FDA product code for SILICONE ELASTOMER SHEETING is MIB.

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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 EXPANDERK974654SILICONE BLOCKS

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Related Devices (Code: MIB)

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.

K241150MISTI Silicone ImplantKeosan Trading Co.K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K193392BioSiCar Silicone ImplantMetalware Technology Corp.

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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