The following data is part of a premarket notification filed by Beacon Laboratories, Inc. with the FDA for Pressure Guard.
| Device ID | K913772 |
| 510k Number | K913772 |
| Device Name: | PRESSURE GUARD |
| Classification | Expander, Skin, Inflatable |
| Applicant | BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield, CO 80020 |
| Contact | Richard P Fleenor |
| Correspondent | Richard P Fleenor BEACON LABORATORIES, INC. 2150 WEST 6TH AVE., UNIT P Broomfield, CO 80020 |
| Product Code | LCJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-23 |
| Decision Date | 1991-11-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PRESSURE GUARD 78093441 not registered Dead/Abandoned |
Smith International, Inc. 2001-11-15 |
![]() PRESSURE GUARD 77483684 not registered Dead/Abandoned |
D.R. Intellectual Properties, Inc. 2008-05-27 |
![]() PRESSURE GUARD 73092305 1062154 Dead/Expired |
HEMOX, INC. 1976-07-02 |
![]() PRESSURE GUARD 73034762 1016342 Live/Registered |
AMERACE CORPORATION 1974-10-16 |