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FDA 510(k)

ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)

K-Number: K943740 · 1994-12-14

Decision Date1994-12-14
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plastics, Inc.. It received FDA 510(k) clearance on 1994-12-14 under 510(k) number K943740. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)?

ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) is a medical device that received FDA 510(k) clearance on 1994-12-14. The listed applicant is Premium Plastics, Inc.. The 510(k) number is K943740.

When did ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) receive FDA 510(k) clearance?

ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) received FDA 510(k) clearance on 1994-12-14, under 510(k) number K943740.

Who is the listed applicant for ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)?

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

What is the FDA product code for ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)?

The FDA product code for ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY) is FMI.

Related Clinical Trials

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.

Other records listing Premium Plastics, 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.

View all 9 devices →

Related Devices (Code: FMI)

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.

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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