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FDA 510(k)

PS-ROUND SURG. DRAIN & CONNECTOR

K-Number: K813377 · 1982-01-05

ApplicantPudenz-Schulte Medical Research Corp.
Decision Date1982-01-05
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PS-ROUND SURG. DRAIN & CONNECTOR 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 1982-01-05 under 510(k) number K813377. 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 PS-ROUND SURG. DRAIN & CONNECTOR?

PS-ROUND SURG. DRAIN & CONNECTOR is a medical device that received FDA 510(k) clearance on 1982-01-05. The listed applicant is Pudenz-Schulte Medical Research Corp.. The 510(k) number is K813377.

When did PS-ROUND SURG. DRAIN & CONNECTOR receive FDA 510(k) clearance?

PS-ROUND SURG. DRAIN & CONNECTOR received FDA 510(k) clearance on 1982-01-05, under 510(k) number K813377.

Who is the listed applicant for PS-ROUND SURG. DRAIN & CONNECTOR?

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 PS-ROUND SURG. DRAIN & CONNECTOR?

The FDA product code for PS-ROUND SURG. DRAIN & CONNECTOR is GCY.

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Other records listing Pudenz-Schulte Medical Research Corp. as applicant

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Related Devices (Code: GCY)

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, 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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