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FDA 510(k)

SAFETY PLUS

K-Number: K945843 · 1995-07-11

ApplicantArent Fox
Decision Date1995-07-11
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAFETY PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Arent Fox. It received FDA 510(k) clearance on 1995-07-11 under 510(k) number K945843. The device is classified under product code EJI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAFETY PLUS?

SAFETY PLUS is a medical device that received FDA 510(k) clearance on 1995-07-11. The listed applicant is Arent Fox. The 510(k) number is K945843.

When did SAFETY PLUS receive FDA 510(k) clearance?

SAFETY PLUS received FDA 510(k) clearance on 1995-07-11, under 510(k) number K945843.

Who is the listed applicant for SAFETY PLUS?

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

What is the FDA product code for SAFETY PLUS?

The FDA product code for SAFETY PLUS is EJI.

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.

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Other records listing Arent Fox 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.

K944053NATURAL RUBBER LATEX SURGEONS GLOVEK945583OCUSYSTEM(ART)K944054POWDER FREE SURGEON'S GLOVE

Related Devices (Code: EJI)

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.

K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc.K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGEHu-Friedy Mfg. Co., LLCK113247ANESTHESIA INJECTION TOOL SETKi Works Co., Ltd.K082249MORPHEUSMeibach Tech LtdaK092943ASPIRATING SYRINGE, NON-ASPIRATING SYRINGEArnold Tuber IndustriesK083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTMiltex, Inc.

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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