510(k) K881091
K881091 is an FDA 510(k) premarket notification submitted by Coe Laboratories, Inc. for the device "OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL". The FDA issued a decision of Substantially Equivalent on June 28, 1988. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Coe Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1988
- Date Received
- March 8, 1988
- 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