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FDA 510(k)

FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01

K-Number: K080621 · 2008-04-29

ApplicantEuropean Custom Manufacturing BV
Decision Date2008-04-29
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 is the device name listed in this FDA 510(k) record. The listed applicant is European Custom Manufacturing BV. It received FDA 510(k) clearance on 2008-04-29 under 510(k) number K080621. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01?

FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 is a medical device that received FDA 510(k) clearance on 2008-04-29. The listed applicant is European Custom Manufacturing BV. The 510(k) number is K080621.

When did FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 receive FDA 510(k) clearance?

FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 received FDA 510(k) clearance on 2008-04-29, under 510(k) number K080621.

Who is the listed applicant for FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01?

The FDA 510(k) record lists European Custom Manufacturing BV as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01?

The FDA product code for FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 is DSA.

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Other records listing European Custom Manufacturing BV 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.

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Official Source

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