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FDA 510(k)

MANAN EPIDURAL NEEDLE

K-Number: K852428 · 1985-06-27

ApplicantManan Manufacturing Co., Inc.
Decision Date1985-06-27
Product CodeGCB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MANAN EPIDURAL NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Manan Manufacturing Co., Inc.. It received FDA 510(k) clearance on 1985-06-27 under 510(k) number K852428. The device is classified under product code GCB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN EPIDURAL NEEDLE?

MANAN EPIDURAL NEEDLE is a medical device that received FDA 510(k) clearance on 1985-06-27. The listed applicant is Manan Manufacturing Co., Inc.. The 510(k) number is K852428.

When did MANAN EPIDURAL NEEDLE receive FDA 510(k) clearance?

MANAN EPIDURAL NEEDLE received FDA 510(k) clearance on 1985-06-27, under 510(k) number K852428.

Who is the listed applicant for MANAN EPIDURAL NEEDLE?

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

What is the FDA product code for MANAN EPIDURAL NEEDLE?

The FDA product code for MANAN EPIDURAL NEEDLE is GCB.

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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 Manan Manufacturing Co., 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.

K873208MANAN TURNER STYLE NEEDLEK864405MANAN CONTRAST MEDIA ADMINISTRATION SETK863848MANAN BREST TUMOR LOCALIZATION NEEDLEK852018ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHRK852501MYELOGRAM PROCEDURE TRAYK851832NAMAN POTTS COURNAND NEEDLE

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Related Devices (Code: GCB)

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.

K974146PARACENTESIS CATHETER DEVICEAllegiance Healthcare Corp.K930568ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.K923028TURKEL PNEUMOTHORAX KITSymbiosis Corp.K900374ADAIR/VERESS NEEDLE INTRODUCER SETMedical Dynamics, Inc.K854327SUBCUTANEOUS TUNNELING NEEDLES & HANDLESConcord Laboratories, Inc.K780896NEEDLES, DESIGN CHANGE, IV CATHETERSJelco Laboratories

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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