The following data is part of a premarket notification filed by Salter Labs with the FDA for Hand Held Pheumatic Powered (disposable) Nebulizer.
Device ID | K870027 |
510k Number | K870027 |
Device Name: | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER |
Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
Applicant | SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
Contact | James N Curti |
Correspondent | James N Curti SALTER LABS P.O. BOX 608 Arvin, CA 93203 |
Product Code | CCQ |
CFR Regulation Number | 868.5640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-05 |
Decision Date | 1987-03-16 |