The following data is part of a premarket notification filed by Intl. Verbandstoff-fabrik Schaffhau with the FDA for Dental Cotton Rolls.
| Device ID | K841327 |
| 510k Number | K841327 |
| Device Name: | DENTAL COTTON ROLLS |
| Classification | Cotton, Roll |
| Applicant | INTL. VERBANDSTOFF-FABRIK SCHAFFHAU 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EFN |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-07-03 |