510(k) K962816
K962816 is an FDA 510(k) premarket notification submitted by Genx Intl., Inc. for the device "SPERM PREPARATION MEDIA". The FDA issued a decision of Substantially Equivalent on November 26, 1996. The device falls under product code MOL (Condom, Synthetic), a Class II device regulated under 21 CFR 884.5300. Genx Intl., Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 26, 1996
- Date Received
- July 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condom, Synthetic
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type