The following data is part of a premarket notification filed by Gambro-hospal, Inc. with the FDA for Tipstop(tm).
| Device ID | K896068 |
| 510k Number | K896068 |
| Device Name: | TIPSTOP(TM) |
| Classification | Tape And Bandage, Adhesive |
| Applicant | GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Contact | Jo Lang |
| Correspondent | Jo Lang GAMBRO-HOSPAL, INC. 460 MCLAWS CIRCLE, SUITE 200 Williamsburg, VA 23185 |
| Product Code | KGX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-19 |
| Decision Date | 1990-09-10 |