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FDA 510(k)

DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING

K-Number: K924277 · 1994-12-07

ApplicantChalgren Enterprises, Inc.
Decision Date1994-12-07
Product CodeHLT
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING is the device name listed in this FDA 510(k) record. The listed applicant is Chalgren Enterprises, Inc.. It received FDA 510(k) clearance on 1994-12-07 under 510(k) number K924277. The device is classified under product code HLT. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING?

DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING is a medical device that received FDA 510(k) clearance on 1994-12-07. The listed applicant is Chalgren Enterprises, Inc.. The 510(k) number is K924277.

When did DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING receive FDA 510(k) clearance?

DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING received FDA 510(k) clearance on 1994-12-07, under 510(k) number K924277.

Who is the listed applicant for DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING?

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

What is the FDA product code for DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING?

The FDA product code for DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING is HLT.

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Other records listing Chalgren Enterprises, 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.

K982950FINE WIRE ELECTRODE MMODEL NUMBERS 221-14-730, 221-24-730, 221-14-550, 221-24-550K960591RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-XXX-24STPK955335DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODEK953354EMG DISC RECORDING ELECTRODEK953361EMG DISC RECORDING ELECTRODEK953356EMG RECORDING RING ELECTRODE

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Related Devices (Code: HLT)

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.

K921815TOMEY PE-300 PORTABLE ERGTomey Corporation USAK841293PANORAMIC LOUPES - VARIOUSKeller Instruments, Inc.K781543ORBIOGRAPHSonometrics Systems, 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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