510(k) K854701
K854701 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "RETRACT-A-CORD". The FDA issued a decision of Substantially Equivalent on March 6, 1986. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1986
- Date Received
- November 21, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Floss, Dental
- Device Class
- Class I
- Regulation Number
- 872.6390
- Review Panel
- DE
- Submission Type