FDA 510(k)

BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.

K-Number: K862303 · 1986-08-12

ApplicantPudenz-Schulte Medical Research Corp.

Decision Date1986-08-12

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. 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 1986-08-12 under 510(k) number K862303. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.?

BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. is a medical device that received FDA 510(k) clearance on 1986-08-12. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K862303.

When did BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. receive FDA 510(k) clearance?

BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. received FDA 510(k) clearance on 1986-08-12, under 510(k) number K862303.

Who is the listed applicant for BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.?

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

What is the FDA product code for BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.?

The FDA product code for BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH. is JXG.

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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.