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FDA 510(k)

SURGI TEK'S DISPOS. INNER CANNULA FOR

K-Number: K822295 · 1982-08-20

ApplicantMedical Engineering Corp.
Decision Date1982-08-20
Product CodeBTO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SURGI TEK'S DISPOS. INNER CANNULA FOR 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 1982-08-20 under 510(k) number K822295. The device is classified under product code BTO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI TEK'S DISPOS. INNER CANNULA FOR?

SURGI TEK'S DISPOS. INNER CANNULA FOR is a medical device that received FDA 510(k) clearance on 1982-08-20. The listed applicant is Medical Engineering Corp.. The 510(k) number is K822295.

When did SURGI TEK'S DISPOS. INNER CANNULA FOR receive FDA 510(k) clearance?

SURGI TEK'S DISPOS. INNER CANNULA FOR received FDA 510(k) clearance on 1982-08-20, under 510(k) number K822295.

Who is the listed applicant for SURGI TEK'S DISPOS. INNER CANNULA FOR?

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 SURGI TEK'S DISPOS. INNER CANNULA FOR?

The FDA product code for SURGI TEK'S DISPOS. INNER CANNULA FOR is BTO.

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Other records listing Medical Engineering Corp. as applicant

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K934141STAND ALONE CYSTOMETROGRAMK905289SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTK903448SURGITEK TEX-SPAN TEXTURED TISSUE EXPANDERK902773SURGITEK(R) FLEXIBLE URETEROSCOPY INTRO/SHEATH SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEM

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Related Devices (Code: BTO)

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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