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FDA 510(k)

SILICONE SUMP DRAIN

K-Number: K862767 · 1986-08-07

ApplicantSil-Med Corp.
Decision Date1986-08-07
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILICONE SUMP 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 1986-08-07 under 510(k) number K862767. The device is classified under product code GBS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILICONE SUMP DRAIN?

SILICONE SUMP DRAIN is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is Sil-Med Corp.. The 510(k) number is K862767.

When did SILICONE SUMP DRAIN receive FDA 510(k) clearance?

SILICONE SUMP DRAIN received FDA 510(k) clearance on 1986-08-07, under 510(k) number K862767.

Who is the listed applicant for SILICONE SUMP 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 SILICONE SUMP DRAIN?

The FDA product code for SILICONE SUMP DRAIN is GBS.

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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

View all 29 devices →

Related Devices (Code: GBS)

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.

K912645ATRIUMS PDR THORACIC CATHETERAtrium Medical Corp.K883887AXIOM ATRAUM WOUND DRAINSAxiom, Inc.K881873INTRODUCTION/DRAINAGE CATHETER & ACCESSSheridan Catheter Corp.K880895URESIL WOUND DRAIN TROCARUresil Corp.K880376NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAPGenesis Industries, Inc.K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, 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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