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FDA 510(k)

MACROPORE PROTECTIVE SHEET

K-Number: K983360 · 1999-03-19

ApplicantPacific Materials and Interfaces
Decision Date1999-03-19
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MACROPORE PROTECTIVE SHEET is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Materials and Interfaces. It received FDA 510(k) clearance on 1999-03-19 under 510(k) number K983360. 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 MACROPORE PROTECTIVE SHEET?

MACROPORE PROTECTIVE SHEET is a medical device that received FDA 510(k) clearance on 1999-03-19. The listed applicant is Pacific Materials and Interfaces. The 510(k) number is K983360.

When did MACROPORE PROTECTIVE SHEET receive FDA 510(k) clearance?

MACROPORE PROTECTIVE SHEET received FDA 510(k) clearance on 1999-03-19, under 510(k) number K983360.

Who is the listed applicant for MACROPORE PROTECTIVE SHEET?

The FDA 510(k) record lists Pacific Materials and Interfaces as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MACROPORE PROTECTIVE SHEET?

The FDA product code for MACROPORE PROTECTIVE SHEET 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 Pacific Materials and Interfaces 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.

K972913MACROPORE PROTECTIVE SHEET (PROTEGO SYSTEM)K972327METAGEN ACTIVELOCK CERCLAGE SYSTEM

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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