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FDA 510(k)

SURGITEK FLAT T-SPAN

K-Number: K884746 · 1989-08-10

ApplicantMedical Engineering Corp.
Decision Date1989-08-10
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

SURGITEK FLAT T-SPAN is the device name listed in this FDA 510(k) record. The listed applicant is Medical Engineering Corp.. It received FDA 510(k) clearance on 1989-08-10 under 510(k) number K884746. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK FLAT T-SPAN?

SURGITEK FLAT T-SPAN is a medical device that received FDA 510(k) clearance on 1989-08-10. The listed applicant is Medical Engineering Corp.. The 510(k) number is K884746.

When did SURGITEK FLAT T-SPAN receive FDA 510(k) clearance?

SURGITEK FLAT T-SPAN received FDA 510(k) clearance on 1989-08-10, under 510(k) number K884746.

Who is the listed applicant for SURGITEK FLAT T-SPAN?

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

What is the FDA product code for SURGITEK FLAT T-SPAN?

The FDA product code for SURGITEK FLAT T-SPAN is LCJ.

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Other records listing Medical Engineering Corp. 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.

K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK883274SURGITEK (R) UROFLOW SYSTEMK881736SURGITEK CO2 DELIVERY SYSTEM

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Related Devices (Code: LCJ)

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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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