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FDA 510(k)

MONOJECTOR MONOLET LANCER

K-Number: K820333 · 1982-03-10

ApplicantSherwood Medical Co.
Decision Date1982-03-10
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MONOJECTOR MONOLET LANCER is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1982-03-10 under 510(k) number K820333. 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 MONOJECTOR MONOLET LANCER?

MONOJECTOR MONOLET LANCER is a medical device that received FDA 510(k) clearance on 1982-03-10. The listed applicant is Sherwood Medical Co.. The 510(k) number is K820333.

When did MONOJECTOR MONOLET LANCER receive FDA 510(k) clearance?

MONOJECTOR MONOLET LANCER received FDA 510(k) clearance on 1982-03-10, under 510(k) number K820333.

Who is the listed applicant for MONOJECTOR MONOLET LANCER?

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

What is the FDA product code for MONOJECTOR MONOLET LANCER?

The FDA product code for MONOJECTOR MONOLET LANCER is FMK.

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Other records listing Sherwood Medical 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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