510(k) K854106
K854106 is an FDA 510(k) premarket notification submitted by Cutter Laboratories, Inc. for the device "BAYSILEX". The FDA issued a decision of Substantially Equivalent on March 17, 1986. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Cutter Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1986
- Date Received
- October 8, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type