510(k) K980964
K980964 is an FDA 510(k) premarket notification submitted by Ls Rubber Sdn Bhd for the device "MAXIMA, TRUSTEX, RIA AND PREMIUM CONDOMS". The FDA issued a decision of Substantially Equivalent on March 12, 1999. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Ls Rubber Sdn Bhd has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1999
- Date Received
- March 16, 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