SILICONE-SILVER PENILE PROSTHESIS-ESK— 510(k) K830667

Name: FDA 510(k) clearance K830667
Creator: U.S. Food and Drug Administration
Published: 1983-10-20

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K830667 for SILICONE-SILVER PENILE PROSTHESIS-ESK, Substantially Equivalent on 1983-10-20. Applicant: Dacomed Corp.. Device class: 2.

Clearance details

Applicant: Dacomed Corp.
Product code: Code FTQ
Device class: Class 2
Regulation: 21 CFR 876.3630
Advisory panel: Gastroenterology, Urology
Date received: 1983-03-04
Decision date: 1983-10-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.