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FDA 510(k)

STRUNG NEURO SPONGE PATTIES-X-RAY-

K-Number: K831914 · 1983-10-31

ApplicantOrmed Mfg., Inc.
Decision Date1983-10-31
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRUNG NEURO SPONGE PATTIES-X-RAY- is the device name listed in this FDA 510(k) record. The listed applicant is Ormed Mfg., Inc.. It received FDA 510(k) clearance on 1983-10-31 under 510(k) number K831914. 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 STRUNG NEURO SPONGE PATTIES-X-RAY-?

STRUNG NEURO SPONGE PATTIES-X-RAY- is a medical device that received FDA 510(k) clearance on 1983-10-31. The listed applicant is Ormed Mfg., Inc.. The 510(k) number is K831914.

When did STRUNG NEURO SPONGE PATTIES-X-RAY- receive FDA 510(k) clearance?

STRUNG NEURO SPONGE PATTIES-X-RAY- received FDA 510(k) clearance on 1983-10-31, under 510(k) number K831914.

Who is the listed applicant for STRUNG NEURO SPONGE PATTIES-X-RAY-?

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

What is the FDA product code for STRUNG NEURO SPONGE PATTIES-X-RAY-?

The FDA product code for STRUNG NEURO SPONGE PATTIES-X-RAY- is GDY.

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Other records listing Ormed Mfg., 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.

K931555ARTROMOT K2 CPMK882530TAPE STRUNG TONSIL SPONGEK882529BUTCHER STRUNG TONSIL SPONGEK882527GAUZE SPONGEK882528CYLINDRICAL SPONGEK880853CHERRY SPONGE

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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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