The following data is part of a premarket notification filed by Gambro Healthcare with the FDA for Hospal Tipstop.
| Device ID | K982818 |
| 510k Number | K982818 |
| Device Name: | HOSPAL TIPSTOP |
| Classification | Bandage, Liquid |
| Applicant | GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Contact | Jeffrey R Shideman |
| Correspondent | Jeffrey R Shideman GAMBRO HEALTHCARE 1185 OAK ST. Lakewood, CO 80215 -4498 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-11 |
| Decision Date | 1998-10-21 |
| Summary: | summary |