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FDA 510(k)

COLOR-EZE PRE-WASHED LAP SPONGES

K-Number: K831913 · 1983-09-26

ApplicantOrmed Mfg., Inc.
Decision Date1983-09-26
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COLOR-EZE PRE-WASHED LAP SPONGES 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 1983-09-26 under 510(k) number K831913. 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 COLOR-EZE PRE-WASHED LAP SPONGES?

COLOR-EZE PRE-WASHED LAP SPONGES is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Ormed Mfg., Inc.. The 510(k) number is K831913.

When did COLOR-EZE PRE-WASHED LAP SPONGES receive FDA 510(k) clearance?

COLOR-EZE PRE-WASHED LAP SPONGES received FDA 510(k) clearance on 1983-09-26, under 510(k) number K831913.

Who is the listed applicant for COLOR-EZE PRE-WASHED LAP SPONGES?

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 COLOR-EZE PRE-WASHED LAP SPONGES?

The FDA product code for COLOR-EZE PRE-WASHED LAP SPONGES 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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