FDA 510(k)

ORAL STEEL CARTRIDGE SYRINGE

K-Number: K941915 · 1995-01-26

Decision Date1995-01-26

Product CodeEJI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ORAL STEEL CARTRIDGE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Robert W. Bauer & Assoc., Inc.. It received FDA 510(k) clearance on 1995-01-26 under 510(k) number K941915. 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 ORAL STEEL CARTRIDGE SYRINGE?

ORAL STEEL CARTRIDGE SYRINGE is a medical device that received FDA 510(k) clearance on 1995-01-26. The listed applicant is Robert W. Bauer & Assoc., Inc.. The 510(k) number is K941915.

When did ORAL STEEL CARTRIDGE SYRINGE receive FDA 510(k) clearance?

ORAL STEEL CARTRIDGE SYRINGE received FDA 510(k) clearance on 1995-01-26, under 510(k) number K941915.

Who is the listed applicant for ORAL STEEL CARTRIDGE SYRINGE?

The FDA 510(k) record lists Robert W. Bauer & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORAL STEEL CARTRIDGE SYRINGE?

The FDA product code for ORAL STEEL CARTRIDGE SYRINGE is EJI.

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Other records listing Robert W. Bauer & Assoc., Inc. as applicant

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Related Devices (Code: EJI)

K171254LeEject 2 Dental Syringe and Needle SystemAdvanced Technology and Capital, Inc.K120659HU-FRIEDY DENTAL CARTRIDGE SYRINGEHu-Friedy Mfg. Co., LLC K113247ANESTHESIA INJECTION TOOL SETKi Works Co., Ltd.K082249MORPHEUSMeibach Tech Ltda K092943ASPIRATING SYRINGE, NON-ASPIRATING SYRINGEArnold Tuber Industries K083796MILTEX 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.