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 |