510(k) K854631
K854631 is an FDA 510(k) premarket notification submitted by Surgicot, Inc. for the device "ASSERT EO BIOLOGICAL TEST PACK". The FDA issued a decision of Substantially Equivalent on May 27, 1986. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Surgicot, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1986
- Date Received
- November 18, 1985
- 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