The following data is part of a premarket notification filed by Pennsylvania Association For The Blind with the FDA for Mask, Surgical-disposable Nsn 6510-00-982-7493.
| Device ID | K903486 |
| 510k Number | K903486 |
| Device Name: | MASK, SURGICAL-DISPOSABLE NSN 6510-00-982-7493 |
| Classification | Mask, Surgical |
| Applicant | PENNSYLVANIA ASSOCIATION FOR THE BLIND WASHINGTON-GREEN COUNTY BRANCH 566 EAST MAIDEN STREET Washington, PA 15301 |
| Contact | Dennis R Charlton |
| Correspondent | Dennis R Charlton PENNSYLVANIA ASSOCIATION FOR THE BLIND WASHINGTON-GREEN COUNTY BRANCH 566 EAST MAIDEN STREET Washington, PA 15301 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-31 |
| Decision Date | 1990-10-23 |