510(k) K792428
K792428 is an FDA 510(k) premarket notification submitted by Coe Laboratories, Inc. for the device "COE-SIL". The FDA issued a decision of Substantially Equivalent on January 23, 1980. The device falls under product code LDG (Kit, Earmold, Impression), a Class I device regulated under 21 CFR 874.3300. Coe Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 1980
- Date Received
- November 27, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Earmold, Impression
- Device Class
- Class I
- Regulation Number
- 874.3300
- Review Panel
- EN
- Submission Type