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FDA 510(k)

MODIFICATION TO SURGICAL MESH POLYMERIC

K-Number: K040787 · 2004-04-14

ApplicantBoston Scientific
Decision Date2004-04-14
Product CodeOTN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SURGICAL MESH POLYMERIC is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2004-04-14 under 510(k) number K040787. The device is classified under product code OTN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SURGICAL MESH POLYMERIC?

MODIFICATION TO SURGICAL MESH POLYMERIC is a medical device that received FDA 510(k) clearance on 2004-04-14. The listed applicant is Boston Scientific. The 510(k) number is K040787.

When did MODIFICATION TO SURGICAL MESH POLYMERIC receive FDA 510(k) clearance?

MODIFICATION TO SURGICAL MESH POLYMERIC received FDA 510(k) clearance on 2004-04-14, under 510(k) number K040787.

Who is the listed applicant for MODIFICATION TO SURGICAL MESH POLYMERIC?

The FDA 510(k) record lists Boston Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO SURGICAL MESH POLYMERIC?

The FDA product code for MODIFICATION TO SURGICAL MESH POLYMERIC is OTN.

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Related Devices (Code: OTN)

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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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