FDA 510(k)

P-S SURGICAL DRAIN

K-Number: K801442 · 1980-07-14

ApplicantPudenz-Schulte Medical Research Corp.

Decision Date1980-07-14

Product CodeGCY

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

P-S SURGICAL DRAIN 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 1980-07-14 under 510(k) number K801442. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P-S SURGICAL DRAIN?

P-S SURGICAL DRAIN is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K801442.

When did P-S SURGICAL DRAIN receive FDA 510(k) clearance?

P-S SURGICAL DRAIN received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801442.

Who is the listed applicant for P-S SURGICAL DRAIN?

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 P-S SURGICAL DRAIN?

The FDA product code for P-S SURGICAL DRAIN is GCY.

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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.