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FDA 510(k)

FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)

K-Number: K063009 · 2006-12-27

ApplicantPraesidia S.R.L.
Decision Date2006-12-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) is the device name listed in this FDA 510(k) record. The listed applicant is Praesidia S.R.L.. It received FDA 510(k) clearance on 2006-12-27 under 510(k) number K063009. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)?

FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) is a medical device that received FDA 510(k) clearance on 2006-12-27. The listed applicant is Praesidia S.R.L.. The 510(k) number is K063009.

When did FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) receive FDA 510(k) clearance?

FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) received FDA 510(k) clearance on 2006-12-27, under 510(k) number K063009.

Who is the listed applicant for FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)?

The FDA 510(k) record lists Praesidia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)?

The FDA product code for FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES) is HRS.

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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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