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FDA 510(k)

BOWEN KNOT PASSER

K-Number: K863148 · 1986-09-05

ApplicantBowen & Company, Inc.
Decision Date1986-09-05
Product CodeHXI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BOWEN KNOT PASSER is the device name listed in this FDA 510(k) record. The listed applicant is Bowen & Company, Inc.. It received FDA 510(k) clearance on 1986-09-05 under 510(k) number K863148. The device is classified under product code HXI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOWEN KNOT PASSER?

BOWEN KNOT PASSER is a medical device that received FDA 510(k) clearance on 1986-09-05. The listed applicant is Bowen & Company, Inc.. The 510(k) number is K863148.

When did BOWEN KNOT PASSER receive FDA 510(k) clearance?

BOWEN KNOT PASSER received FDA 510(k) clearance on 1986-09-05, under 510(k) number K863148.

Who is the listed applicant for BOWEN KNOT PASSER?

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

What is the FDA product code for BOWEN KNOT PASSER?

The FDA product code for BOWEN KNOT PASSER is HXI.

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Other records listing Bowen & Company, 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.

K896898BOWEN ELECTRODE SKIN PREPATORY CLEANSERK896538DISPOSABLE 45 DEGREE SHAVERK873766STERNAL POWER AWLK872098CREMEEN ALVEOLAR BONE CALIPERK871325BOWEN REUSEABLE/DISPOSABLE ELECTRODEK87088245 DEGREE SHAVER

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Related Devices (Code: HXI)

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.

K863146BOWEN SUTURE PASSERBowen & Company, Inc.

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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