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FDA 510(k)

SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING

K-Number: K971613 · 1997-05-22

ApplicantTechnical Products, Inc.
Decision Date1997-05-22
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Technical Products, Inc.. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K971613. The device is classified under product code MIB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING?

SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Technical Products, Inc.. The 510(k) number is K971613.

When did SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING receive FDA 510(k) clearance?

SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING received FDA 510(k) clearance on 1997-05-22, under 510(k) number K971613.

Who is the listed applicant for SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING?

The FDA 510(k) record lists Technical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING?

The FDA product code for SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBING is MIB.

Related Clinical Trials

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Other records listing Technical Products, Inc. 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.

K013321SILICONE TRACHEAL T-TUBESK973385OVAL SHAPESK973166DOW CORNING SILASTIC ELASTOMER Q7-4750K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAK954116SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP

Related Devices (Code: MIB)

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.

K241150MISTI Silicone ImplantKeosan Trading Co.K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.K222748ShiNeo Silicone ImplantShineo Technology Co., Ltd.K200073AugMENTA Penile ImplantAugmenta, LLCK220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.K193392BioSiCar Silicone ImplantMetalware Technology Corp.

Official Source

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