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FDA 510(k)

FLOSPIK

K-Number: K853767 · 1985-12-02

ApplicantMedelco , Ltd.
Decision Date1985-12-02
Product CodeJES
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLOSPIK is the device name listed in this FDA 510(k) record. The listed applicant is Medelco , Ltd.. It received FDA 510(k) clearance on 1985-12-02 under 510(k) number K853767. The device is classified under product code JES. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOSPIK?

FLOSPIK is a medical device that received FDA 510(k) clearance on 1985-12-02. The listed applicant is Medelco , Ltd.. The 510(k) number is K853767.

When did FLOSPIK receive FDA 510(k) clearance?

FLOSPIK received FDA 510(k) clearance on 1985-12-02, under 510(k) number K853767.

Who is the listed applicant for FLOSPIK?

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

What is the FDA product code for FLOSPIK?

The FDA product code for FLOSPIK is JES.

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 Medelco , Ltd. 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.

K831472ULTRA PULSATORK831473ULTRA PULSATOR MFK831474MINI PULSATOR

Related Devices (Code: JES)

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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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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