The following data is part of a premarket notification filed by Intl. Verbandstoff-fabrik Schaffhau with the FDA for Dental Cotton Rolls, Sterile And Non-sterile.
| Device ID | K861338 |
| 510k Number | K861338 |
| Device Name: | DENTAL COTTON ROLLS, STERILE AND NON-STERILE |
| Classification | Cotton, Roll |
| Applicant | INTL. VERBANDSTOFF-FABRIK SCHAFFHAU CH-8212 NEUHAUSEN AM RHEINFALL Switzlerland, CH |
| Contact | Aebi |
| Correspondent | Aebi INTL. VERBANDSTOFF-FABRIK SCHAFFHAU CH-8212 NEUHAUSEN AM RHEINFALL Switzlerland, CH |
| Product Code | EFN |
| CFR Regulation Number | 872.6050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-07 |
| Decision Date | 1986-08-06 |