FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
K Number: K991892
·
Decision Aug 19, 1999
Classifications
1
FEI Numbers
77
Registration Numbers
77
Same Product Code
400
Applicant Total
5
Review Days
77
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Basic Information
- Device Name
- TRUSTEX MINT FLAVORED CONDOM IN GREEN COLOR, IMPULSE MINT FLAVORED CONDOM IN GREEN COLOR
- K Number
- K991892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Line One Laboratories
- Date Received
- June 3, 1999
- Decision Date
- August 19, 1999
- 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 Line One Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K970633 | TUSTEX FLAVORED CONDOMS | Mar 21, 1997 | Substantially Equivalent |
| K964599 | TRUSTEX CHOCOLATE FLAVORED CONDOM IN BLACK COLOR | Feb 14, 1997 | Substantially Equivalent |
| K964598 | TRUSTEX COLA FLAVORD CONDOM | Feb 14, 1997 | Substantially Equivalent |
| K964591 | TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR | Feb 13, 1997 | Substantially Equivalent |