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FDA 510(k)

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY

K-Number: K955174 · 1996-01-22

ApplicantSodem Diffusion SA
Decision Date1996-01-22
Product CodeGET
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Sodem Diffusion SA. It received FDA 510(k) clearance on 1996-01-22 under 510(k) number K955174. The device is classified under product code GET. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY?

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY is a medical device that received FDA 510(k) clearance on 1996-01-22. The listed applicant is Sodem Diffusion SA. The 510(k) number is K955174.

When did SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY receive FDA 510(k) clearance?

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY received FDA 510(k) clearance on 1996-01-22, under 510(k) number K955174.

Who is the listed applicant for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY?

The FDA 510(k) record lists Sodem Diffusion SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY?

The FDA product code for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMY is GET.

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 Sodem Diffusion SA 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.

K954717SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMYK954080SODEM HIGH SPEED SYSTEM

Related Devices (Code: GET)

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.

K960473AESCULAP POWER SYSTEM HANDPIECEAesculap, Inc.K942987NUCLEOTOME L KITSurgical Dynamics, Inc.K954076MIDAS REX DRILL ATTACHMENTS & TWIST DRILLSMidas Rex Pneumatic Tools, Inc.K953433MIDAS REX TELESCOPING SYSTEMMidas Rex Pneumatic Tools, Inc.K953432ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLSMidas Rex Pneumatic Tools, Inc.K952463GS & GS20 SURGICAL TOOL SYSTEMMidas Rex Pneumatic Tools, 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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