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FDA 510(k)

SAFETY INJECTION SYSTEM

K-Number: K962999 · 1997-01-22

ApplicantIntegritech, Inc.
Decision Date1997-01-22
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAFETY INJECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Integritech, Inc.. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K962999. 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 INJECTION SYSTEM?

SAFETY INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Integritech, Inc.. The 510(k) number is K962999.

When did SAFETY INJECTION SYSTEM receive FDA 510(k) clearance?

SAFETY INJECTION SYSTEM received FDA 510(k) clearance on 1997-01-22, under 510(k) number K962999.

Who is the listed applicant for SAFETY INJECTION SYSTEM?

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

What is the FDA product code for SAFETY INJECTION SYSTEM?

The FDA product code for SAFETY INJECTION SYSTEM is EJI.

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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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