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FDA 510(k)

SURGITEK RECONSTRUC-NIPPLE PROSTHESIS

K-Number: K842748 · 1984-09-26

ApplicantMedical Engineering Corp.
Decision Date1984-09-26
Product Code
DecisionSubstantially Equivalent

Device Summary

SURGITEK RECONSTRUC-NIPPLE PROSTHESIS 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 1984-09-26 under 510(k) number K842748. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGITEK RECONSTRUC-NIPPLE PROSTHESIS?

SURGITEK RECONSTRUC-NIPPLE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1984-09-26. The listed applicant is Medical Engineering Corp.. The 510(k) number is K842748.

When did SURGITEK RECONSTRUC-NIPPLE PROSTHESIS receive FDA 510(k) clearance?

SURGITEK RECONSTRUC-NIPPLE PROSTHESIS received FDA 510(k) clearance on 1984-09-26, under 510(k) number K842748.

Who is the listed applicant for SURGITEK RECONSTRUC-NIPPLE PROSTHESIS?

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

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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 SETK884746SURGITEK FLAT T-SPANK883274SURGITEK (R) UROFLOW SYSTEM

View all 28 devices →

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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