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FDA 510(k)

EPIDURAL ANESTHESIA NEEDLES

K-Number: K854816 · 1985-12-19

ApplicantReganes, Inc.
Decision Date1985-12-19
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

EPIDURAL ANESTHESIA NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is Reganes, Inc.. It received FDA 510(k) clearance on 1985-12-19 under 510(k) number K854816. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIDURAL ANESTHESIA NEEDLES?

EPIDURAL ANESTHESIA NEEDLES is a medical device that received FDA 510(k) clearance on 1985-12-19. The listed applicant is Reganes, Inc.. The 510(k) number is K854816.

When did EPIDURAL ANESTHESIA NEEDLES receive FDA 510(k) clearance?

EPIDURAL ANESTHESIA NEEDLES received FDA 510(k) clearance on 1985-12-19, under 510(k) number K854816.

Who is the listed applicant for EPIDURAL ANESTHESIA NEEDLES?

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

What is the FDA product code for EPIDURAL ANESTHESIA NEEDLES?

The FDA product code for EPIDURAL ANESTHESIA NEEDLES is BSP.

Related Clinical Trials

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 Reganes, 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.

K880181REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY

Related Devices (Code: BSP)

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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Official Source

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