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FDA 510(k)

DOW CORNING SILASTIC ELASTOMER Q7-4750

K-Number: K973166 · 1997-11-21

ApplicantTechnical Products, Inc.
Decision Date1997-11-21
Product CodeMIB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DOW CORNING SILASTIC ELASTOMER Q7-4750 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 1997-11-21 under 510(k) number K973166. 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 DOW CORNING SILASTIC ELASTOMER Q7-4750?

DOW CORNING SILASTIC ELASTOMER Q7-4750 is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Technical Products, Inc.. The 510(k) number is K973166.

When did DOW CORNING SILASTIC ELASTOMER Q7-4750 receive FDA 510(k) clearance?

DOW CORNING SILASTIC ELASTOMER Q7-4750 received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973166.

Who is the listed applicant for DOW CORNING SILASTIC ELASTOMER Q7-4750?

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 DOW CORNING SILASTIC ELASTOMER Q7-4750?

The FDA product code for DOW CORNING SILASTIC ELASTOMER Q7-4750 is MIB.

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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 SHAPESK971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRAK971613SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBING/SIL-TEC RADIOPAQUE TUBINGK954116SILICONE 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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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