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FDA 510(k)

LARGE VOLUME CLOSED WOUND SUCTION DRAIN

K-Number: K822032 · 1982-08-16

ApplicantAmerican Heyer Schulte
Decision Date1982-08-16
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LARGE VOLUME CLOSED WOUND SUCTION DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is American Heyer Schulte. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K822032. 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 LARGE VOLUME CLOSED WOUND SUCTION DRAIN?

LARGE VOLUME CLOSED WOUND SUCTION DRAIN is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is American Heyer Schulte. The 510(k) number is K822032.

When did LARGE VOLUME CLOSED WOUND SUCTION DRAIN receive FDA 510(k) clearance?

LARGE VOLUME CLOSED WOUND SUCTION DRAIN received FDA 510(k) clearance on 1982-08-16, under 510(k) number K822032.

Who is the listed applicant for LARGE VOLUME CLOSED WOUND SUCTION DRAIN?

The FDA 510(k) record lists American Heyer Schulte as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LARGE VOLUME CLOSED WOUND SUCTION DRAIN?

The FDA product code for LARGE VOLUME CLOSED WOUND SUCTION DRAIN is GCY.

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Other records listing American Heyer Schulte 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.

K840172VENTRAL WALL DEFECT REDUCT SILOK834593ONE-PIECE SHUNTK833502RADOVAN SUBCUTANEOUS TISSUE EXPANDERK833698AMER. V. MUELLER SURG. STAPLES ILAK833704AMER. V. MUELLER SURGICALSTAPLES-CARTRK832738HEYER-SCHULTE AFTERLOADING CATHETER

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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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