510(k) K983518
K983518 is an FDA 510(k) premarket notification submitted by Ansell, Inc. for the device "LIFESTYLES XTRA PLEASURE". The FDA issued a decision of Substantially Equivalent on July 6, 1999. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ansell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 1999
- Date Received
- October 7, 1998
- 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