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FDA 510(k)

NUCLEOTOME L KIT

K-Number: K942987 · 1995-10-30

ApplicantSurgical Dynamics, Inc.
Decision Date1995-10-30
Product CodeGET
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NUCLEOTOME L KIT is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Dynamics, Inc.. It received FDA 510(k) clearance on 1995-10-30 under 510(k) number K942987. 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 NUCLEOTOME L KIT?

NUCLEOTOME L KIT is a medical device that received FDA 510(k) clearance on 1995-10-30. The listed applicant is Surgical Dynamics, Inc.. The 510(k) number is K942987.

When did NUCLEOTOME L KIT receive FDA 510(k) clearance?

NUCLEOTOME L KIT received FDA 510(k) clearance on 1995-10-30, under 510(k) number K942987.

Who is the listed applicant for NUCLEOTOME L KIT?

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

What is the FDA product code for NUCLEOTOME L KIT?

The FDA product code for NUCLEOTOME L KIT is GET.

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Other records listing Surgical Dynamics, 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.

K960046SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPEK954193SURGICAL DYNAMICS 30K WORKING CHANNEL SCOPE & INSTRUMENT SETK950495SUGICAL DYNAMICS ENDOSCOPY IRRIGATION PUMP, CATALOG #3-4000K931109NUCLEOTOME E KITK921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEMK923525NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR

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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.K955174SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMYSodem Diffusion SAK954076MIDAS 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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