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FDA 510(k)

SUBLIMINATOR

K-Number: K961457 · 1996-07-18

ApplicantHealex Products, Inc.
Decision Date1996-07-18
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUBLIMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Healex Products, Inc.. It received FDA 510(k) clearance on 1996-07-18 under 510(k) number K961457. 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 SUBLIMINATOR?

SUBLIMINATOR is a medical device that received FDA 510(k) clearance on 1996-07-18. The listed applicant is Healex Products, Inc.. The 510(k) number is K961457.

When did SUBLIMINATOR receive FDA 510(k) clearance?

SUBLIMINATOR received FDA 510(k) clearance on 1996-07-18, under 510(k) number K961457.

Who is the listed applicant for SUBLIMINATOR?

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

What is the FDA product code for SUBLIMINATOR?

The FDA product code for SUBLIMINATOR 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 Healex Products, 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.

K030727POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENTK954976POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION)

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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