The following data is part of a premarket notification filed by Lancaster County Blind Assoc. with the FDA for Surgical Mask.
| Device ID | K905209 |
| 510k Number | K905209 |
| Device Name: | SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | LANCASTER COUNTY BLIND ASSOC. 244 NORTH QUEEN ST. Lancaster, PA 17603 |
| Contact | Dennis Steiner |
| Correspondent | Dennis Steiner LANCASTER COUNTY BLIND ASSOC. 244 NORTH QUEEN ST. Lancaster, PA 17603 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-02-21 |