510(k) K982380
K982380 is an FDA 510(k) premarket notification submitted by Pleasure Latex Products Sdn. Bhd. for the device "SURE". The FDA issued a decision of Substantially Equivalent on February 26, 1999. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Pleasure Latex Products Sdn. Bhd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1999
- Date Received
- July 8, 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