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FDA 510(k)

MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM

K-Number: K943346 · 1994-10-04

ApplicantPatton, Boggs & Blow
Decision Date1994-10-04
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Patton, Boggs & Blow. It received FDA 510(k) clearance on 1994-10-04 under 510(k) number K943346. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM?

MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Patton, Boggs & Blow. The 510(k) number is K943346.

When did MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM receive FDA 510(k) clearance?

MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM received FDA 510(k) clearance on 1994-10-04, under 510(k) number K943346.

Who is the listed applicant for MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM?

The FDA 510(k) record lists Patton, Boggs & Blow as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM?

The FDA product code for MANUAL SURGICAL INST. AND ACC. TO KLS MINI OSTEOSYNTHESIS SYSTEM is JEY.

Related Clinical Trials

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.

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Other records listing Patton, Boggs & Blow 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.

K943347KLS MINI OSTEOSYNTHESIS SYSTEMK943348KLS CHIN PLATE SYSTEMK943345MANUAL SURGICAL INST. AND ACC. TO KLS CHIN PLATE SYSTEMK821799FITKIT I CHECKUP KITK823825NOSITE UV INTERIM SPECTACLES

Related Devices (Code: JEY)

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.

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical CorporationK253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OYK241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

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.

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