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FDA 510(k)

GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.

K-Number: K802982 · 1980-12-19

ApplicantStanford Laboratories
Decision Date1980-12-19
Product CodeGDY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. is the device name listed in this FDA 510(k) record. The listed applicant is Stanford Laboratories. It received FDA 510(k) clearance on 1980-12-19 under 510(k) number K802982. 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 GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.?

GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. is a medical device that received FDA 510(k) clearance on 1980-12-19. The listed applicant is Stanford Laboratories. The 510(k) number is K802982.

When did GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. receive FDA 510(k) clearance?

GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. received FDA 510(k) clearance on 1980-12-19, under 510(k) number K802982.

Who is the listed applicant for GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.?

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

What is the FDA product code for GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG.?

The FDA product code for GAUZE, ABSORBABLE X-RAY DETECT. LAP SPG. is GDY.

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Other records listing Stanford Laboratories 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.

K811167FOCUS STERILE SYRINGES

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

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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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