The following data is part of a premarket notification filed by Medic-aid Ltd. with the FDA for Sidestream Drug Nebulizer.
Device ID | K914152 |
510k Number | K914152 |
Device Name: | SIDESTREAM DRUG NEBULIZER |
Classification | Nebulizer (direct Patient Interface) |
Applicant | MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp, GB |
Contact | M. R Pollington |
Correspondent | M. R Pollington MEDIC-AID LTD. HOOK LANE, PAGHAM, Sussex, U.k. Po21 3pp, GB |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-16 |
Decision Date | 1992-05-05 |