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FDA 510(k)

SYSTENET

K-Number: K832544 · 1983-11-29

ApplicantAmerican Intl. Medical Supply Co.
Decision Date1983-11-29
Product CodeKGX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYSTENET is the device name listed in this FDA 510(k) record. The listed applicant is American Intl. Medical Supply Co.. It received FDA 510(k) clearance on 1983-11-29 under 510(k) number K832544. The device is classified under product code KGX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTENET?

SYSTENET is a medical device that received FDA 510(k) clearance on 1983-11-29. The listed applicant is American Intl. Medical Supply Co.. The 510(k) number is K832544.

When did SYSTENET receive FDA 510(k) clearance?

SYSTENET received FDA 510(k) clearance on 1983-11-29, under 510(k) number K832544.

Who is the listed applicant for SYSTENET?

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

What is the FDA product code for SYSTENET?

The FDA product code for SYSTENET is KGX.

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 American Intl. Medical Supply 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.

K882114AMISCO U-100 INSULIN SYRINGE

Related Devices (Code: KGX)

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.

K001240SERAGARD INJECTION PATCHPlatinum Services, Inc.K983368CARE BAND ANTIBACTERIAL BANDAGESAso Corp.K972914SYVEK PATCHMarine Polymer Technologies, Inc.K943314ADHESIVE BANDAGES WITH OTC DRUGJohnson & Johnson Consumer Products, Inc.K952606TARGETT PATCHCutting Edge Technologies, Inc.K954007PARALLELJohnson & Johnson Consumer Products, 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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