DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE— 510(k) K920409

Name: FDA 510(k) clearance K920409
Creator: U.S. Food and Drug Administration
Published: 1992-05-11

Substantially Equivalent

Dacomed Corp.

FDA 510(k) clearance K920409 for DACOMED BATTERY OPERATED VACUUM ERECTION DEVICE, Substantially Equivalent on 1992-05-11. Applicant: Dacomed Corp.. Device class: 2.

Clearance details

Applicant: Dacomed Corp.
Product code: Code LKY
Device class: Class 2
Regulation: 21 CFR 876.5020
Advisory panel: Gastroenterology, Urology
Date received: 1992-01-31
Decision date: 1992-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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