FDA 510(k)

10-0 CASSETTE

K-Number: K942516 · 1994-07-25

ApplicantSurgin Surgical Instrumentation, Inc.

Decision Date1994-07-25

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

10-0 CASSETTE is the device name listed in this FDA 510(k) record. The listed applicant is Surgin Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1994-07-25 under 510(k) number K942516. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 10-0 CASSETTE?

10-0 CASSETTE is a medical device that received FDA 510(k) clearance on 1994-07-25. The listed applicant is Surgin Surgical Instrumentation, Inc.. The 510(k) number is K942516.

When did 10-0 CASSETTE receive FDA 510(k) clearance?

10-0 CASSETTE received FDA 510(k) clearance on 1994-07-25, under 510(k) number K942516.

Who is the listed applicant for 10-0 CASSETTE?

The FDA 510(k) record lists Surgin Surgical Instrumentation, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 10-0 CASSETTE?

The FDA product code for 10-0 CASSETTE is HQC.

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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.