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FDA 510(k)

PROLASTIC SHEETING

K-Number: K954382 · 1995-11-29

ApplicantPillar Surgical
Decision Date1995-11-29
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PROLASTIC SHEETING is the device name listed in this FDA 510(k) record. The listed applicant is Pillar Surgical. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K954382. 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 PROLASTIC SHEETING?

PROLASTIC SHEETING is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Pillar Surgical. The 510(k) number is K954382.

When did PROLASTIC SHEETING receive FDA 510(k) clearance?

PROLASTIC SHEETING received FDA 510(k) clearance on 1995-11-29, under 510(k) number K954382.

Who is the listed applicant for PROLASTIC SHEETING?

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

What is the FDA product code for PROLASTIC SHEETING?

The FDA product code for PROLASTIC SHEETING is MIB.

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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.

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Other records listing Pillar Surgical 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.

K991970SCAREASE SHEETS & SCAREASE GEL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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