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FDA 510(k)

DURALASTIC SHEETING II

K-Number: K961057 · 1996-05-16

ApplicantRand Scientific Corp.
Decision Date1996-05-16
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DURALASTIC SHEETING II is the device name listed in this FDA 510(k) record. The listed applicant is Rand Scientific Corp.. It received FDA 510(k) clearance on 1996-05-16 under 510(k) number K961057. 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 DURALASTIC SHEETING II?

DURALASTIC SHEETING II is a medical device that received FDA 510(k) clearance on 1996-05-16. The listed applicant is Rand Scientific Corp.. The 510(k) number is K961057.

When did DURALASTIC SHEETING II receive FDA 510(k) clearance?

DURALASTIC SHEETING II received FDA 510(k) clearance on 1996-05-16, under 510(k) number K961057.

Who is the listed applicant for DURALASTIC SHEETING II?

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

What is the FDA product code for DURALASTIC SHEETING II?

The FDA product code for DURALASTIC SHEETING II is MIB.

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Other records listing Rand Scientific 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.

K963856RAND NASAL PACKINGK961081SPIRIT RIDGE SILICONE CARVING BLOCKK955777PMMA CLASICK961080MEDIAL MALAR IMPLANTK961072PEC IMPLANTK961071THE MAGNUM CHIN IMPLANT

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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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