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FDA 510(k)

STERILE SILICONE TUBING

K-Number: K810071 · 1981-02-12

ApplicantMedspec Corp.
Decision Date1981-02-12
Product CodeGBS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERILE SILICONE TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Medspec Corp.. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K810071. 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 STERILE SILICONE TUBING?

STERILE SILICONE TUBING is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is Medspec Corp.. The 510(k) number is K810071.

When did STERILE SILICONE TUBING receive FDA 510(k) clearance?

STERILE SILICONE TUBING received FDA 510(k) clearance on 1981-02-12, under 510(k) number K810071.

Who is the listed applicant for STERILE SILICONE TUBING?

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

What is the FDA product code for STERILE SILICONE TUBING?

The FDA product code for STERILE SILICONE TUBING is GBS.

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Other records listing Medspec 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.

K813012STERILE BASIN SETSK812710STERILE LAPAROTOMY SPONGES-X-RAY DETECTK812707STERILE DISSECTOR SPONGES-X-RAY DETECTK812711STERILE GAUZE PADS 12PLYK812709STERILE DENTAL ROLLK810069STERILE AIRWAY

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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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