510(k) K831136
K831136 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "DOUBLE BOW TOOTH SEPARATOR". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code JEP (Retainer, Matrix), a Class I device regulated under 21 CFR 872.4565. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1983
- Date Received
- April 7, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retainer, Matrix
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type