PULMOMIST
Nebulizer (direct Patient Interface)
GLOBAL MEDICAL ENT., INC.
The following data is part of a premarket notification filed by Global Medical Ent., Inc. with the FDA for Pulmomist.
Pre-market Notification Details
| Device ID | K952326 |
| 510k Number | K952326 |
| Device Name: | PULMOMIST |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | GLOBAL MEDICAL ENT., INC. 1590 WEST 35TH PL. Hialeah, FL 33012 |
| Contact | Salvador Castaner |
| Correspondent | Salvador Castaner GLOBAL MEDICAL ENT., INC. 1590 WEST 35TH PL. Hialeah, FL 33012 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1996-02-27 |
Trademark Results [PULMOMIST]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PULMOMIST 74684502 not registered Dead/Abandoned |
Castaner, Salvador 1995-06-05 |
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