The following data is part of a premarket notification filed by Denver Splint Co. with the FDA for Shippert Pressure Bandage.
| Device ID | K940798 |
| 510k Number | K940798 |
| Device Name: | SHIPPERT PRESSURE BANDAGE |
| Classification | Tape And Bandage, Adhesive |
| Applicant | DENVER SPLINT CO. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Contact | Sarah M Lake |
| Correspondent | Sarah M Lake DENVER SPLINT CO. 7002 SOUTH REVERE PARKWAY, SUITE 60 Englewood, CO 80112 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-22 |
| Decision Date | 1994-09-28 |