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FDA 510(k)

MANDIBLE MANIPULATOR

K-Number: K884308 · 1989-03-31

ApplicantLeonard Medical, Inc.
Decision Date1989-03-31
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MANDIBLE MANIPULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Leonard Medical, Inc.. It received FDA 510(k) clearance on 1989-03-31 under 510(k) number K884308. 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 MANDIBLE MANIPULATOR?

MANDIBLE MANIPULATOR is a medical device that received FDA 510(k) clearance on 1989-03-31. The listed applicant is Leonard Medical, Inc.. The 510(k) number is K884308.

When did MANDIBLE MANIPULATOR receive FDA 510(k) clearance?

MANDIBLE MANIPULATOR received FDA 510(k) clearance on 1989-03-31, under 510(k) number K884308.

Who is the listed applicant for MANDIBLE MANIPULATOR?

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

What is the FDA product code for MANDIBLE MANIPULATOR?

The FDA product code for MANDIBLE MANIPULATOR is EKJ.

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Other records listing Leonard Medical, 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.

K951854LEONARD ARM - SUPPORT ARM - ENDOSCOPIC ACCESSORYK903536SMALL JOINT INSTRUMENTS (SCISSOR HANDLE)K895685SMALL JOINT HAND INSTRUMENTSK884314LEONARD MEDICAL 1.7MM ARTHROSCOPEK873139VARUS AND VALGUS LEG HOLDERK864117SUPPORT ARM

View all 7 devices →

Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, 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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