The following data is part of a premarket notification filed by Cottrell, Ltd. with the FDA for Barrier All Film.
| Device ID | K952234 |
| 510k Number | K952234 |
| Device Name: | BARRIER ALL FILM |
| Classification | Unit, Oral Irrigation |
| Applicant | COTTRELL, LTD. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Contact | Frank S Casciani |
| Correspondent | Frank S Casciani COTTRELL, LTD. 49 PLAIN ST. North Attleboro, MA 02760 -4153 |
| Product Code | EFS |
| CFR Regulation Number | 872.6510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1995-07-31 |