FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10
K Number: K851290
·
Decision May 22, 1985
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
5
Review Days
51
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Basic Information
- Device Name
- LOBESAFE PLAIN CONDOM DOZEN CONDOMS/BOX,PC-10
- K Number
- K851290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Manexim Multicorp, Ltd.
- Date Received
- April 1, 1985
- Decision Date
- May 22, 1985
- 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 Manexim Multicorp, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K863707 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE SC-40 | Sep 26, 1986 | Substantially Equivalent |
| K863706 | LOVESAFE CONTRACEPTIVE CONDOMS, TYPE NL-50 | Sep 26, 1986 | Substantially Equivalent |
| K851292 | LOVESAFE DOTTY CONDOM ONE DZ. CODOMS/BOX, DC-20 | May 23, 1985 | Substantially Equivalent |
| K851291 | LOVESAFE PLAIN CONDOM 1/4 DZ. CONDOMS/BOX PC-30 | May 22, 1985 | Substantially Equivalent |