The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Pressurizer.
| Device ID | K951988 |
| 510k Number | K951988 |
| Device Name: | PRESSURIZER |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | PROMEDIC, INC. 10415 BRIGGS COURT Indianapolis, IN 46256 -9719 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden PROMEDIC, INC. 10415 BRIGGS COURT Indianapolis, IN 46256 -9719 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-04-27 |
| Decision Date | 1995-06-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRESSURIZER 74536892 not registered Dead/Abandoned |
Just Toys, Inc. 1994-06-13 |
![]() PRESSURIZER 72315191 0884546 Dead/Expired |
UNDER SEA INDUSTRIES, INC. 1968-12-26 |