510(k) K990925
K990925 is an FDA 510(k) premarket notification submitted by Hardcover Products, Inc. for the device "MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)". The FDA issued a decision of Substantially Equivalent on June 17, 1999. The device falls under product code HIS (Condom), a Class II device regulated under 21 CFR 884.5300. Hardcover Products, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 1999
- Date Received
- March 19, 1999
- Clearance Type
- Abbreviated
- 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