510(k) K881422
K881422 is an FDA 510(k) premarket notification submitted by Coe Laboratories, Inc. for the device "COE PAK AUTO MIX, REGULAR OR HARD SET". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Coe Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 1988
- Date Received
- April 5, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Dental
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- DE
- Submission Type