The following data is part of a premarket notification filed by Laboratory For Applied Immunology, Inc. with the FDA for Rosenthal-french Nebulization Dosimeter.
| Device ID | K860800 |
| 510k Number | K860800 |
| Device Name: | ROSENTHAL-FRENCH NEBULIZATION DOSIMETER |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | LABORATORY FOR APPLIED IMMUNOLOGY, INC. 8318 ARLINGTON BLVD., SUITE 306 Fairfax, VA 22031 |
| Contact | Richard R Rosenthal |
| Correspondent | Richard R Rosenthal LABORATORY FOR APPLIED IMMUNOLOGY, INC. 8318 ARLINGTON BLVD., SUITE 306 Fairfax, VA 22031 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-04 |
| Decision Date | 1986-03-27 |