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FDA 510(k)

OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES

K-Number: K926596 · 1994-06-10

ApplicantOwens Industries, Inc.
Decision Date1994-06-10
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Owens Industries, Inc.. It received FDA 510(k) clearance on 1994-06-10 under 510(k) number K926596. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES?

OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1994-06-10. The listed applicant is Owens Industries, Inc.. The 510(k) number is K926596.

When did OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES receive FDA 510(k) clearance?

OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES received FDA 510(k) clearance on 1994-06-10, under 510(k) number K926596.

Who is the listed applicant for OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES?

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

What is the FDA product code for OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES?

The FDA product code for OWENS ENDOSCOPIC INSTRUMENTS AND ACCESSORIES is HET.

Related Clinical Trials

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Other records listing Owens Industries, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K926594OWENS LAPAROSCOPY INSTRUMENTS AND ACCESSORIESK926595OWENS BIOPSY FORCEPSK932796OWENS TROCAR

Related Devices (Code: HET)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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