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FDA 510(k)

FLAT DRAIN

K-Number: K813063 · 1981-12-18

ApplicantSil-Med Corp.
Decision Date1981-12-18
Product CodeGBW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FLAT DRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Sil-Med Corp.. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813063. The device is classified under product code GBW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLAT DRAIN?

FLAT DRAIN is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Sil-Med Corp.. The 510(k) number is K813063.

When did FLAT DRAIN receive FDA 510(k) clearance?

FLAT DRAIN received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813063.

Who is the listed applicant for FLAT DRAIN?

The FDA 510(k) record lists Sil-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLAT DRAIN?

The FDA product code for FLAT DRAIN is GBW.

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Other records listing Sil-Med 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.

K972521NAVIGATOR (STYLET) 2006K961392ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT IIK961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINK961295SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCARK960099PENROSE DRAIN MODELS 6001 - 6007K955463GRIP-A-BOOTS

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Related Devices (Code: GBW)

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.

K992907INTRADUCERTaut, Inc.K992904MINI-PORTTaut, Inc.K972112INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450Taut, Inc.K961194ANTIMICROBIAL MEDIASTINAL SILICONE DRAINSil-Med Corp.K960426MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETERMedical Components, Inc.K942709MEDIASTINAL SILICONE DRAINSSil-Med Corp.

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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