FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TROJAN POLYURETHANE CONDOM (MODIFICATION)
K Number: K955672
·
Decision Aug 29, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
22
Applicant Total
20
Review Days
302
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Basic Information
- Device Name
- TROJAN POLYURETHANE CONDOM (MODIFICATION)
- K Number
- K955672
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Carter Products
- Date Received
- November 1, 1995
- Decision Date
- August 29, 1996
- Product Code
- MOL
- 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 |
|---|---|---|---|
| MOL | Condom, Synthetic | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Carter Products
| K Number | Device Name | ||
|---|---|---|---|
| K942697 | TROJAN POLYURETHANE CONDOM | Jun 22, 1995 | Substantially Equivalent |
| K912901 | TROJAN (TM-TBD) CONDOM | Feb 3, 1992 | Substantially Equivalent |
| K904782 | ANSWER QUICK AND SIMPLE AT-HOME PREGNANCY TEST | Dec 6, 1990 | Substantially Equivalent |
| K904273 | MAGNUM PLUS LATEX CONDOMS WITH SPERMICIDAL LUB. | Oct 31, 1990 | Substantially Equivalent |
| K901202 | TROJAN NATURALAMB LUBRICATED NATURAL MODIFIED | Jun 19, 1990 | Substantially Equivalent |
| K901201 | TROJAN RIBBED LATEX CONDOMS W/SPERM. MODIFIED | Apr 16, 1990 | Substantially Equivalent |
| K901198 | TROJAN PLUS 2 LATEX CONDOMS W/SPERMICIDAL MODIFIED | Apr 16, 1990 | Substantially Equivalent |
| K901193 | TROJAN PLUS LUBRI. LATEX CONDOMS (MODIFIED LABEL) | Apr 16, 1990 | Substantially Equivalent |
| K901197 | TROJAN EXTRA STRENGTH LUBRI. CONDOMS MODI. LABEL | Apr 16, 1990 | Substantially Equivalent |
| K901194 | TROJAN RIBBED LUBRI. LATEX CONDOMS MODIFIED LABEL | Apr 16, 1990 | Substantially Equivalent |