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FDA 510(k)

ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE

K-Number: K954718 · 1996-02-29

ApplicantEllman Intl., Inc.
Decision Date1996-02-29
Product CodeHEE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Ellman Intl., Inc.. It received FDA 510(k) clearance on 1996-02-29 under 510(k) number K954718. The device is classified under product code HEE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE?

ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE is a medical device that received FDA 510(k) clearance on 1996-02-29. The listed applicant is Ellman Intl., Inc.. The 510(k) number is K954718.

When did ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE receive FDA 510(k) clearance?

ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE received FDA 510(k) clearance on 1996-02-29, under 510(k) number K954718.

Who is the listed applicant for ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE?

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

What is the FDA product code for ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE?

The FDA product code for ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE is HEE.

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Related Devices (Code: HEE)

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.

K052365CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGERocket Medical PlcK021224ENDOCERVICAL BLOCK NEEDLEWallach Surgical Devices, Inc.K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEAvid Medical, Inc.K983897CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208GRi Mos. S.R.L.K980238GYNEX EXTENDED REACH NEEDLEGynex Corp.K973671ENDOCERVICAL BLOCK NEEDLEA & A Medical, Inc.

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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