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FDA 510(k)

MINIJECT

K-Number: K991888 · 1999-08-25

ApplicantSpartan Ultrasonics, Inc.
Decision Date1999-08-25
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINIJECT is the device name listed in this FDA 510(k) record. The listed applicant is Spartan Ultrasonics, Inc.. It received FDA 510(k) clearance on 1999-08-25 under 510(k) number K991888. 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 MINIJECT?

MINIJECT is a medical device that received FDA 510(k) clearance on 1999-08-25. The listed applicant is Spartan Ultrasonics, Inc.. The 510(k) number is K991888.

When did MINIJECT receive FDA 510(k) clearance?

MINIJECT received FDA 510(k) clearance on 1999-08-25, under 510(k) number K991888.

Who is the listed applicant for MINIJECT?

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

What is the FDA product code for MINIJECT?

The FDA product code for MINIJECT 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 Spartan Ultrasonics, 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.

K002753SPARTAN A-10

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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