FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
K Number: K932983
·
Decision Jul 7, 1994
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
11
Review Days
384
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Basic Information
- Device Name
- COLORED CONDOMS (ESSENTIALS, MI VIDA, JIFFI)
- K Number
- K932983
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sime Health, Ltd.
- Date Received
- June 18, 1993
- Decision Date
- July 7, 1994
- Product Code
- HIS
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIS | Condom | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Sime Health, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K954025 | SIME SURGICAL POWDERFREE | Nov 15, 1995 | Substantially Equivalent |
| K954051 | SIME POWDERFREE PLUS | Nov 15, 1995 | Substantially Equivalent |
| K932985 | AROMATIC CONDOM, ESSENTIALS, MI VIDA & JIFFI | Jun 16, 1995 | Substantially Equivalent |
| K932982 | SPERMICIDAL LUBRIC. CONDOMS (ESSENTIALS, MI VIDA, JIFFI) | Jul 7, 1994 | Substantially Equivalent |
| K932984 | UNLUBRICATED CONDOM, ESSENTIALS, MI VIDA & JIFFI | Jul 7, 1994 | Substantially Equivalent |
| K940797 | SIME SURGICAL LATEX GLOVE | May 9, 1994 | Substantially Equivalent |
| K931491 | SIME HEALTH SIME HYPOALLERGENIC | Oct 15, 1993 | Substantially Equivalent |
| K914276 | SIME HEALTH SIME POWDERFREE EXAMINATION GLOVES | Dec 4, 1992 | Substantially Equivalent |
| K913813 | JIFFI CONDOM (RUBBER) CONTRACEPTIVE | Jun 1, 1992 | Substantially Equivalent |
| K913048 | SIME TRUFEEL | Sep 19, 1991 | Substantially Equivalent |