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FDA 510(k)

INCASE EXTENSIBLE BAG--NON-STERILE

K-Number: K951420 · 1995-06-08

ApplicantAlpha Surgical, Inc.
Decision Date1995-06-08
Product CodeLYU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INCASE EXTENSIBLE BAG--NON-STERILE is the device name listed in this FDA 510(k) record. The listed applicant is Alpha Surgical, Inc.. It received FDA 510(k) clearance on 1995-06-08 under 510(k) number K951420. The device is classified under product code LYU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INCASE EXTENSIBLE BAG--NON-STERILE?

INCASE EXTENSIBLE BAG--NON-STERILE is a medical device that received FDA 510(k) clearance on 1995-06-08. The listed applicant is Alpha Surgical, Inc.. The 510(k) number is K951420.

When did INCASE EXTENSIBLE BAG--NON-STERILE receive FDA 510(k) clearance?

INCASE EXTENSIBLE BAG--NON-STERILE received FDA 510(k) clearance on 1995-06-08, under 510(k) number K951420.

Who is the listed applicant for INCASE EXTENSIBLE BAG--NON-STERILE?

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

What is the FDA product code for INCASE EXTENSIBLE BAG--NON-STERILE?

The FDA product code for INCASE EXTENSIBLE BAG--NON-STERILE is LYU.

Related Clinical Trials

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.

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Other records listing Alpha Surgical, 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.

K942699AIRFRAME SURGICAL DRAPE SUPPORT

Related Devices (Code: LYU)

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.

K011755STRYKER T4 HYTREL (R) TOGASStryker Corp.K965237NURSES BOUFFANT CAPCopioumed Intl., Inc.K970988FAR-EAST BOUFFANT CAPSFar East Science & Technology Development Co., Ltd.K964364DISPOSABLE APRONInstrument Makar, Inc.K961791DEPUY DISPOSABLE FILTER/HOODDepuy, Inc.K961454AMMI MAGNI-GUARDAmerican Medical Mfg., Inc.

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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