510(k) K883335
K883335 is an FDA 510(k) premarket notification submitted by Colgate-Palmolive Co. for the device "COLGATE DENTAL FLOSS". The FDA issued a decision of Substantially Equivalent on August 26, 1988. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Colgate-Palmolive Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1988
- Date Received
- August 9, 1988
- 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