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FDA 510(k)

OPRATEX ABDOMINAL PAD

K-Number: K802798 · 1980-12-11

ApplicantSecol Co.
Decision Date1980-12-11
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPRATEX ABDOMINAL PAD is the device name listed in this FDA 510(k) record. The listed applicant is Secol Co.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802798. 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 OPRATEX ABDOMINAL PAD?

OPRATEX ABDOMINAL PAD is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Secol Co.. The 510(k) number is K802798.

When did OPRATEX ABDOMINAL PAD receive FDA 510(k) clearance?

OPRATEX ABDOMINAL PAD received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802798.

Who is the listed applicant for OPRATEX ABDOMINAL PAD?

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

What is the FDA product code for OPRATEX ABDOMINAL PAD?

The FDA product code for OPRATEX ABDOMINAL PAD is GDY.

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Other records listing Secol Co. 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.

K802790SOLVALINEK810111CELLONA PLASTER VARNISHK810109METAL SPLINTSK810110COBBLER'S CHIP SPLINTSK802794PRO-OPHTA STICKSK802793LOMATUELL OINTMENT DRESSING

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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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