510(k) K980019
K980019 is an FDA 510(k) premarket notification submitted by Reddy Medtech Health Products , Ltd. for the device "HTL MALE CONDOM". The FDA issued a decision of Substantially Equivalent on April 1, 1998. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Reddy Medtech Health Products , Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1998
- Date Received
- January 2, 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