FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THE SAXON SPERMICIDAL CONDOM
K Number: K883467
·
Decision Oct 26, 1988
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
5
Review Days
75
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Basic Information
- Device Name
- THE SAXON SPERMICIDAL CONDOM
- K Number
- K883467
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Circle Rubber Corp.
- Date Received
- August 12, 1988
- Decision Date
- October 26, 1988
- 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 Circle Rubber Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K890407 | THE SAXON SPERMICIDAL CONDOM W/2 YEAR EXPIRATION | May 16, 1989 | Substantially Equivalent |
| K872736 | PROPHYLACTIC (CONDOM) | Oct 20, 1987 | Substantially Equivalent |
| K842502 | WRINKLE CHAPEAU BLACKY | Sep 21, 1984 | Substantially Equivalent |
| K813172 | CONDOM-MULTIPAL STYLES | Mar 5, 1982 | Substantially Equivalent |