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FDA 510(k)

CARELET SAFETY LANCET

K-Number: K931828 · 1993-10-15

ApplicantGainor Medical Europe, Ltd.
Decision Date1993-10-15
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CARELET SAFETY LANCET is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1993-10-15 under 510(k) number K931828. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARELET SAFETY LANCET?

CARELET SAFETY LANCET is a medical device that received FDA 510(k) clearance on 1993-10-15. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K931828.

When did CARELET SAFETY LANCET receive FDA 510(k) clearance?

CARELET SAFETY LANCET received FDA 510(k) clearance on 1993-10-15, under 510(k) number K931828.

Who is the listed applicant for CARELET SAFETY LANCET?

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

What is the FDA product code for CARELET SAFETY LANCET?

The FDA product code for CARELET SAFETY LANCET is FMK.

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 Gainor Medical Europe, 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.

K926448I.V. ADMINISTRATION SETK931827CLEANLET, CLEANLET XL & KIDSK922441SURESEAL BANDAGEK913333I.V. PRIMING SETK902422NEEDLE, ASPIRATION & INJECTION, DISPOSABLEK902420CATHETER, NASAL, OXYGEN

View all 13 devices →

Related Devices (Code: FMK)

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.

K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694safety lancetTianjin Huahong Technology Co., Ltd.

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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