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FDA 510(k)

BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED

K-Number: K884515 · 1989-01-10

ApplicantGatewood and Associates, Ltd.
Decision Date1989-01-10
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED is the device name listed in this FDA 510(k) record. The listed applicant is Gatewood and Associates, Ltd.. It received FDA 510(k) clearance on 1989-01-10 under 510(k) number K884515. 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 BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED?

BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED is a medical device that received FDA 510(k) clearance on 1989-01-10. The listed applicant is Gatewood and Associates, Ltd.. The 510(k) number is K884515.

When did BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED receive FDA 510(k) clearance?

BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED received FDA 510(k) clearance on 1989-01-10, under 510(k) number K884515.

Who is the listed applicant for BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED?

The FDA 510(k) record lists Gatewood and Associates, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED?

The FDA product code for BONE FILE, SELDIN, #11-TSK BONE FILE, DOUBLE-ENDED is EKJ.

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Other records listing Gatewood and Associates, Ltd. 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.

K884514FORCEPS, TOWEL, BACKHAUS-TSK (BRAND) TOWEL

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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