FDA 510(k)

STAT PAK

K-Number: K943820 · 1994-11-02

Decision Date1994-11-02

Product CodeEKJ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

STAT PAK is the device name listed in this FDA 510(k) record. The listed applicant is Magnum Instruments, Inc.. It received FDA 510(k) clearance on 1994-11-02 under 510(k) number K943820. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STAT PAK?

STAT PAK is a medical device that received FDA 510(k) clearance on 1994-11-02. The listed applicant is Magnum Instruments, Inc.. The 510(k) number is K943820.

When did STAT PAK receive FDA 510(k) clearance?

STAT PAK received FDA 510(k) clearance on 1994-11-02, under 510(k) number K943820.

Who is the listed applicant for STAT PAK?

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

What is the FDA product code for STAT PAK?

The FDA product code for STAT PAK is EKJ.

Other records listing Magnum Instruments, 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.

K943351MAUNAL DISPOSABLE DENTAL INSTRUMENTS

Related Devices (Code: EKJ)

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943351MAUNAL DISPOSABLE DENTAL INSTRUMENTSMagnum Instruments, 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.