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FDA 510(k)

BONE & MARROW CLLECTION SYSTEM

K-Number: K971268 · 1997-07-03

ApplicantBiomedical International Corp.
Decision Date1997-07-03
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BONE & MARROW CLLECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical International Corp.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K971268. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE & MARROW CLLECTION SYSTEM?

BONE & MARROW CLLECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is Biomedical International Corp.. The 510(k) number is K971268.

When did BONE & MARROW CLLECTION SYSTEM receive FDA 510(k) clearance?

BONE & MARROW CLLECTION SYSTEM received FDA 510(k) clearance on 1997-07-03, under 510(k) number K971268.

Who is the listed applicant for BONE & MARROW CLLECTION SYSTEM?

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

What is the FDA product code for BONE & MARROW CLLECTION SYSTEM?

The FDA product code for BONE & MARROW CLLECTION SYSTEM is GEY.

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Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., 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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