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FDA 510(k)

EROSA DISPOSABLE HYPODERMIC NEEDLE

K-Number: K853980 · 1985-10-18

ApplicantRose KG
Decision Date1985-10-18
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EROSA DISPOSABLE HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Rose KG. It received FDA 510(k) clearance on 1985-10-18 under 510(k) number K853980. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EROSA DISPOSABLE HYPODERMIC NEEDLE?

EROSA DISPOSABLE HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 1985-10-18. The listed applicant is Rose KG. The 510(k) number is K853980.

When did EROSA DISPOSABLE HYPODERMIC NEEDLE receive FDA 510(k) clearance?

EROSA DISPOSABLE HYPODERMIC NEEDLE received FDA 510(k) clearance on 1985-10-18, under 510(k) number K853980.

Who is the listed applicant for EROSA DISPOSABLE HYPODERMIC NEEDLE?

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

What is the FDA product code for EROSA DISPOSABLE HYPODERMIC NEEDLE?

The FDA product code for EROSA DISPOSABLE HYPODERMIC NEEDLE is GAA.

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Related Devices (Code: GAA)

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.

K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc.K102274ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENTArvik Enterprises/ Mini Lap TechnologiesK011586IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGEDiametrics Medical, Inc.K994151PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICESXimed/Prosure/InjectxK983200INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEXXimed/Prosure/InjectxK974741MANAN ACCURA NEEDLEMedical Device Technologies, Inc.

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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