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FDA 510(k)

LUMBAR PUNCTURE KIT

K-Number: K970287 · 1997-04-07

ApplicantB.Braun Medical, Inc.
Decision Date1997-04-07
Product CodeFMJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

LUMBAR PUNCTURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 1997-04-07 under 510(k) number K970287. The device is classified under product code FMJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMBAR PUNCTURE KIT?

LUMBAR PUNCTURE KIT is a medical device that received FDA 510(k) clearance on 1997-04-07. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K970287.

When did LUMBAR PUNCTURE KIT receive FDA 510(k) clearance?

LUMBAR PUNCTURE KIT received FDA 510(k) clearance on 1997-04-07, under 510(k) number K970287.

Who is the listed applicant for LUMBAR PUNCTURE KIT?

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

What is the FDA product code for LUMBAR PUNCTURE KIT?

The FDA product code for LUMBAR PUNCTURE KIT is FMJ.

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Related Devices (Code: FMJ)

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.

K170305Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH MedizintechnologieK032432BUSSE HOSPITAL DISPOSABLES SPINAL MANOMETERBusse Hospital Disposables, Inc.K963570SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22)Smiths Industries Medical Systems, Inc.K910089MEGA LUMBAR PUNCTURE KITMegadyne Medical Products, Inc.K882405HYPODERMIC NEEDLE SHEATH HOLDERAnsr Ent., 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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