510(k) K810839
K810839 is an FDA 510(k) premarket notification submitted by Moyco Industries, Inc. for the device "SPOTAR". The FDA issued a decision of Substantially Equivalent on April 29, 1981. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Moyco Industries, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1981
- Date Received
- March 27, 1981
- 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