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FDA 510(k)

GREEN RADIOPAQUE IN SURG. SPONGES

K-Number: K770924 · 1977-08-10

ApplicantKendall Research Center
Decision Date1977-08-10
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GREEN RADIOPAQUE IN SURG. SPONGES is the device name listed in this FDA 510(k) record. The listed applicant is Kendall Research Center. It received FDA 510(k) clearance on 1977-08-10 under 510(k) number K770924. The device is classified under product code GDY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GREEN RADIOPAQUE IN SURG. SPONGES?

GREEN RADIOPAQUE IN SURG. SPONGES is a medical device that received FDA 510(k) clearance on 1977-08-10. The listed applicant is Kendall Research Center. The 510(k) number is K770924.

When did GREEN RADIOPAQUE IN SURG. SPONGES receive FDA 510(k) clearance?

GREEN RADIOPAQUE IN SURG. SPONGES received FDA 510(k) clearance on 1977-08-10, under 510(k) number K770924.

Who is the listed applicant for GREEN RADIOPAQUE IN SURG. SPONGES?

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

What is the FDA product code for GREEN RADIOPAQUE IN SURG. SPONGES?

The FDA product code for GREEN RADIOPAQUE IN SURG. SPONGES is GDY.

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Other records listing Kendall Research Center 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.

K802225TENDER-SORB DRAIN SPONGESK781357T.E.D. SEQUENTIAL COMPRESSION SLEEVESK780408MICRONET LIGHT DRESSING SPONGEK780062CATHETER/HEMOSTATIC/GERIATRICK780120ANESTHESIA TRAY, CAUDALK772133URINE SPECIMEN COLLECTING DEVICE

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Related Devices (Code: GDY)

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.

K972634ULTRACELL SUCTION SPONGEUltracell Medical Technologies, Inc.K960236CPR LAP SPONGESCustom Pack ReliabilityK955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEStryker Corp.K955322PROTEC X-RAY DETECTABLE GAUZE SPONGEDerivados DE Gasa, S.A. DE C.V.K953830KENSORBKentron Health Care, Inc.K953059KITTNER DISSECTORMedical Perspectives 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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