510(k) K964591
K964591 is an FDA 510(k) premarket notification submitted by Line One Laboratories for the device "TRUSTEX GRAPE FLAVORED CONDOM IN PURPLE COLOR". The FDA issued a decision of Substantially Equivalent on February 13, 1997. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Line One Laboratories has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 1997
- Date Received
- November 15, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type