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FDA 510(k)

BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR

K-Number: K864754 · 1986-12-22

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1986-12-22
Product Code
DecisionSubstantially Equivalent

Device Summary

BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Pudenz-Schulte Medical Research Corp.. It received FDA 510(k) clearance on 1986-12-22 under 510(k) number K864754. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR?

BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR is a medical device that received FDA 510(k) clearance on 1986-12-22. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K864754.

When did BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR receive FDA 510(k) clearance?

BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR received FDA 510(k) clearance on 1986-12-22, under 510(k) number K864754.

Who is the listed applicant for BECKER EXTERNAL DRAINAGE & MONITOR SYSTEM TROCAR?

The FDA 510(k) record lists Pudenz-Schulte Medical Research Corp. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Pudenz-Schulte Medical Research Corp. 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.

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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.

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