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FDA 510(k)

THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*

K-Number: K973281 · 1997-11-03

ApplicantUnited States Surgical, A Division of Tyco Healthc
Decision Date1997-11-03
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* is the device name listed in this FDA 510(k) record. The listed applicant is United States Surgical, A Division of Tyco Healthc. It received FDA 510(k) clearance on 1997-11-03 under 510(k) number K973281. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*?

THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* is a medical device that received FDA 510(k) clearance on 1997-11-03. The listed applicant is United States Surgical, A Division of Tyco Healthc. The 510(k) number is K973281.

When did THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* receive FDA 510(k) clearance?

THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* received FDA 510(k) clearance on 1997-11-03, under 510(k) number K973281.

Who is the listed applicant for THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*?

The FDA 510(k) record lists United States Surgical, A Division of Tyco Healthc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC*?

The FDA product code for THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* is MAI.

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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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