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FDA 510(k)

CHIBA SKINNY NEEDLE

K-Number: K813460 · 1982-01-07

ApplicantOcean Medical Products, Ltd.
Decision Date1982-01-07
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CHIBA SKINNY NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Ocean Medical Products, Ltd.. It received FDA 510(k) clearance on 1982-01-07 under 510(k) number K813460. 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 CHIBA SKINNY NEEDLE?

CHIBA SKINNY NEEDLE is a medical device that received FDA 510(k) clearance on 1982-01-07. The listed applicant is Ocean Medical Products, Ltd.. The 510(k) number is K813460.

When did CHIBA SKINNY NEEDLE receive FDA 510(k) clearance?

CHIBA SKINNY NEEDLE received FDA 510(k) clearance on 1982-01-07, under 510(k) number K813460.

Who is the listed applicant for CHIBA SKINNY NEEDLE?

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

What is the FDA product code for CHIBA SKINNY NEEDLE?

The FDA product code for CHIBA SKINNY NEEDLE is GAA.

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Other records listing Ocean Medical Products, 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.

K882013SOFT TISSUE BIOPSY DEVICEK870896NOTCH-NEEDLE, WESCOTT STYLEK843719SINGLE WALL INTRODUCER NEEDLEK823693MYELOGRAPHY NEEDLEK823692SPINAL NEEDLEK813462MADAYAG TYPE NEEDLE

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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

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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