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FDA 510(k)

SURGITEK DISPOSABLE FLO-RESTER

K-Number: K781336 · 1978-10-10

ApplicantMedical Engineering Corp.
Decision Date1978-10-10
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SURGITEK DISPOSABLE FLO-RESTER 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 1978-10-10 under 510(k) number K781336. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK DISPOSABLE FLO-RESTER?

SURGITEK DISPOSABLE FLO-RESTER is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Medical Engineering Corp.. The 510(k) number is K781336.

When did SURGITEK DISPOSABLE FLO-RESTER receive FDA 510(k) clearance?

SURGITEK DISPOSABLE FLO-RESTER received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781336.

Who is the listed applicant for SURGITEK DISPOSABLE FLO-RESTER?

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 DISPOSABLE FLO-RESTER?

The FDA product code for SURGITEK DISPOSABLE FLO-RESTER is DWS.

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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: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems

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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