SILASTIC BRAND PENILE IMPLANT— 510(k) K780484

Name: FDA 510(k) clearance K780484
Creator: U.S. Food and Drug Administration
Published: 1978-07-17

Substantially Equivalent

Dow Corning Corp. Healthcare Industries Materials

FDA 510(k) clearance K780484 for SILASTIC BRAND PENILE IMPLANT, Substantially Equivalent on 1978-07-17. Applicant: Dow Corning Corp. Healthcare Industries Materials. Device class: 2.

Clearance details

Applicant: Dow Corning Corp. Healthcare Industries Materials
Product code: Code FIQ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1978-03-27
Decision date: 1978-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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