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FDA 510(k)

SOLITAIRE

K-Number: K972101 · 1997-09-29

ApplicantHeraeus Kulzer, Inc.
Decision Date1997-09-29
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOLITAIRE is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1997-09-29 under 510(k) number K972101. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOLITAIRE?

SOLITAIRE is a medical device that received FDA 510(k) clearance on 1997-09-29. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K972101.

When did SOLITAIRE receive FDA 510(k) clearance?

SOLITAIRE received FDA 510(k) clearance on 1997-09-29, under 510(k) number K972101.

Who is the listed applicant for SOLITAIRE?

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

What is the FDA product code for SOLITAIRE?

The FDA product code for SOLITAIRE is KLE.

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Other records listing Heraeus Kulzer, 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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: KLE)

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

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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