510(k) K011573
K011573 is an FDA 510(k) premarket notification submitted by Conception Technologies for the device "HYALURONIDASE IN HTF MEDIUM; HYALURONIDASE IN EBSS MEDIUM". The FDA issued a decision of Substantially Equivalent on July 2, 2001. The device falls under product code MQL (Media, Reproductive), a Class II device regulated under 21 CFR 884.6180. Conception Technologies has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2001
- Date Received
- May 21, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Reproductive
- Device Class
- Class II
- Regulation Number
- 884.6180
- Review Panel
- OB
- Submission Type