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FDA 510(k)

INTRODUCER, CAT. #INT-05FR.

K-Number: K771042 · 1977-07-13

ApplicantSorensen Research
Decision Date1977-07-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRODUCER, CAT. #INT-05FR. is the device name listed in this FDA 510(k) record. The listed applicant is Sorensen Research. It received FDA 510(k) clearance on 1977-07-13 under 510(k) number K771042. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRODUCER, CAT. #INT-05FR.?

INTRODUCER, CAT. #INT-05FR. is a medical device that received FDA 510(k) clearance on 1977-07-13. The listed applicant is Sorensen Research. The 510(k) number is K771042.

When did INTRODUCER, CAT. #INT-05FR. receive FDA 510(k) clearance?

INTRODUCER, CAT. #INT-05FR. received FDA 510(k) clearance on 1977-07-13, under 510(k) number K771042.

Who is the listed applicant for INTRODUCER, CAT. #INT-05FR.?

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

What is the FDA product code for INTRODUCER, CAT. #INT-05FR.?

The FDA product code for INTRODUCER, CAT. #INT-05FR. is DYB.

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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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