The following data is part of a premarket notification filed by Lasersafe, Inc. with the FDA for Lasersafe Personnel And Patient Shields.
| Device ID | K852405 |
| 510k Number | K852405 |
| Device Name: | LASERSAFE PERSONNEL AND PATIENT SHIELDS |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | LASERSAFE, INC. 641 RIDGEFIELD AVE. Pittsburgh, PA 15216 |
| Contact | Teeple, M.d. |
| Correspondent | Teeple, M.d. LASERSAFE, INC. 641 RIDGEFIELD AVE. Pittsburgh, PA 15216 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-06 |
| Decision Date | 1985-10-01 |