FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KIMONO PLUS OTHERS (MULTIPLE) CONDOMS
K Number: K884470
·
Decision Mar 31, 1989
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
17
Review Days
157
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Basic Information
- Device Name
- KIMONO PLUS OTHERS (MULTIPLE) CONDOMS
- K Number
- K884470
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Mayer Laboratories
- Date Received
- October 25, 1988
- Decision Date
- March 31, 1989
- 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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|---|---|---|---|
| K252158 | Sagami Original 002 Polyurethane Male Condom | Mar 30, 2026 | Substantially Equivalent |
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| K946374 | KIMONO MICROTHIN | Nov 8, 1995 | Substantially Equivalent |
| K946376 | MAXX | Sep 22, 1995 | Substantially Equivalent |
| K943064 | KIMONO (CONDOMS) | Sep 22, 1995 | Substantially Equivalent |
| K925869 | SHEATHES, STERILE SHEATHES | Jan 6, 1994 | Substantially Equivalent |
| K926049 | DIGITEX, DIGITEX HYPOALLERGENIC | Jul 22, 1993 | Substantially Equivalent |
| K904375 | KIMONO PLUS | Nov 26, 1990 | Substantially Equivalent |
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| K904840 | ORION PLUS/MODIFICATION | Nov 20, 1990 | Substantially Equivalent |