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FDA 510(k)

SYRINGE, ENT

K-Number: K810251 · 1981-03-11

ApplicantMegaplast, Inc.
Decision Date1981-03-11
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYRINGE, ENT is the device name listed in this FDA 510(k) record. The listed applicant is Megaplast, Inc.. It received FDA 510(k) clearance on 1981-03-11 under 510(k) number K810251. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRINGE, ENT?

SYRINGE, ENT is a medical device that received FDA 510(k) clearance on 1981-03-11. The listed applicant is Megaplast, Inc.. The 510(k) number is K810251.

When did SYRINGE, ENT receive FDA 510(k) clearance?

SYRINGE, ENT received FDA 510(k) clearance on 1981-03-11, under 510(k) number K810251.

Who is the listed applicant for SYRINGE, ENT?

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

What is the FDA product code for SYRINGE, ENT?

The FDA product code for SYRINGE, ENT is KYZ.

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Other records listing Megaplast, Inc. 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.

K822158OPEN HEART TRAY (CUSTOM DESIGNED)K821313SURGICAL UTILITY DRAPEK820423SUTURE REMOVAL TRAYK820136URINARY DRAINAGE BAGK810249TRAY, CATHERIZATION, URETHRALK810250TRAY, IRRIGATION

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Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K102563SINGLE CANNULA EXTENDED APPLICATORMicromedics, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, 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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