510(k) K800847
K800847 is an FDA 510(k) premarket notification submitted by Mcb Manufacturing Chemists, Inc. for the device "ENTELLAN". The FDA issued a decision of Substantially Equivalent on May 8, 1980. The device falls under product code KEP (Media, Mounting, Oil Soluble), a Class I device regulated under 21 CFR 864.4010. Mcb Manufacturing Chemists, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 1980
- Date Received
- April 15, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Mounting, Oil Soluble
- Device Class
- Class I
- Regulation Number
- 864.4010
- Review Panel
- PA
- Submission Type