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FDA 510(k)

SIMPLA S4, S5, S7

K-Number: K941447 · 1994-07-18

ApplicantSimpla Plastics , Ltd.
Decision Date1994-07-18
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIMPLA S4, S5, S7 is the device name listed in this FDA 510(k) record. The listed applicant is Simpla Plastics , Ltd.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K941447. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLA S4, S5, S7?

SIMPLA S4, S5, S7 is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Simpla Plastics , Ltd.. The 510(k) number is K941447.

When did SIMPLA S4, S5, S7 receive FDA 510(k) clearance?

SIMPLA S4, S5, S7 received FDA 510(k) clearance on 1994-07-18, under 510(k) number K941447.

Who is the listed applicant for SIMPLA S4, S5, S7?

The FDA 510(k) record lists Simpla Plastics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLA S4, S5, S7?

The FDA product code for SIMPLA S4, S5, S7 is KNX.

Related Clinical Trials

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.

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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