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FDA 510(k)

MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT

K-Number: K083796 · 2009-03-09

ApplicantMiltex, Inc.
Decision Date2009-03-09
Product CodeEJI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Miltex, Inc.. It received FDA 510(k) clearance on 2009-03-09 under 510(k) number K083796. 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 MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT?

MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT is a medical device that received FDA 510(k) clearance on 2009-03-09. The listed applicant is Miltex, Inc.. The 510(k) number is K083796.

When did MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT receive FDA 510(k) clearance?

MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT received FDA 510(k) clearance on 2009-03-09, under 510(k) number K083796.

Who is the listed applicant for MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT?

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

What is the FDA product code for MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT?

The FDA product code for MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT is EJI.

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Other records listing Miltex, 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.

K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESK092855MILTEX MEMBRANE TACK KITK072563MILTEX RIGID CONTAINER SYSTEMSK061033MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)K052018MILTEX LIGATING CLIPK050570MILTEX RIGID STERILIZATION CONTAINER SYSTEM

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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 IndustriesK081694DENJECTORDxm Co., Ltd.

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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