510(k) K972708
K972708 is an FDA 510(k) premarket notification submitted by Cottrell, Ltd. for the device "ENDO-SPOR PLUS / HYPROCIDE". The FDA issued a decision of Substantially Equivalent on September 13, 1999. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Cottrell, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1999
- Date Received
- July 21, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilant, Medical Devices
- Device Class
- Class II
- Regulation Number
- 880.6885
- Review Panel
- HO
- Submission Type