The following data is part of a premarket notification filed by Seamless Div., Professional Medical Products with the FDA for Standard Nebulizer Heater.
| Device ID | K895913 |
| 510k Number | K895913 |
| Device Name: | STANDARD NEBULIZER HEATER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SEAMLESS DIV., PROFESSIONAL MEDICAL PRODUCTS 1909 N.E. 25TH AVE. Ocala, FL 32670 |
| Contact | Lee Cutright |
| Correspondent | Lee Cutright SEAMLESS DIV., PROFESSIONAL MEDICAL PRODUCTS 1909 N.E. 25TH AVE. Ocala, FL 32670 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-10 |
| Decision Date | 1989-12-22 |