The following data is part of a premarket notification filed by Whitehall Laboratories, Inc. with the FDA for Kolynos Dental Floss.
| Device ID | K882571 |
| 510k Number | K882571 |
| Device Name: | KOLYNOS DENTAL FLOSS |
| Classification | Floss, Dental |
| Applicant | WHITEHALL LABORATORIES, INC. 685 THIRD AVE. New York, NY 10017 |
| Contact | Kenneth R Palmer |
| Correspondent | Kenneth R Palmer WHITEHALL LABORATORIES, INC. 685 THIRD AVE. New York, NY 10017 |
| Product Code | JES |
| CFR Regulation Number | 872.6390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-22 |
| Decision Date | 1988-10-12 |