510(k) K960777
K960777 is an FDA 510(k) premarket notification submitted by Mdt Corp., Inc. for the device "MDT UNISPORE AND SPOR-TEST BIOLOGICALINDICATOR". The FDA issued a decision of Substantially Equivalent on May 23, 1996. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Mdt Corp., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1996
- Date Received
- February 26, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type