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FDA 510(k)

ORIGIN TACKER SYSTEM

K-Number: K944415 · 1994-11-28

ApplicantOrigin Medsystems, Inc.
Decision Date1994-11-28
Product CodeOCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ORIGIN TACKER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Origin Medsystems, Inc.. It received FDA 510(k) clearance on 1994-11-28 under 510(k) number K944415. The device is classified under product code OCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORIGIN TACKER SYSTEM?

ORIGIN TACKER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-11-28. The listed applicant is Origin Medsystems, Inc.. The 510(k) number is K944415.

When did ORIGIN TACKER SYSTEM receive FDA 510(k) clearance?

ORIGIN TACKER SYSTEM received FDA 510(k) clearance on 1994-11-28, under 510(k) number K944415.

Who is the listed applicant for ORIGIN TACKER SYSTEM?

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

What is the FDA product code for ORIGIN TACKER SYSTEM?

The FDA product code for ORIGIN TACKER SYSTEM is OCW.

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Official Source

View on FDA Database →

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