UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI— 510(k) K932984

Name: FDA 510(k) clearance K932984
Creator: U.S. Food and Drug Administration
Published: 1994-07-07

Substantially Equivalent

Sime Health, Ltd.

FDA 510(k) clearance K932984 for UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI, Substantially Equivalent on 1994-07-07. Applicant: Sime Health, Ltd.. Device class: 2.

Clearance details

Applicant: Sime Health, Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1993-06-18
Decision date: 1994-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seattle, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Sime Health, Ltd.

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K954025 — SIME SURGICAL POWDERFREE1995-11-15
K954051 — SIME POWDERFREE PLUS1995-11-15
K932985 — AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI1995-06-16
K932982 — SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI)1994-07-07
K932983 — COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)1994-07-07

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