The following data is part of a premarket notification filed by Astra Meditec Ab with the FDA for Abdovac (tm), Bellovac (tm) And Exudrain.
| Device ID | K920819 |
| 510k Number | K920819 |
| Device Name: | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | ASTRA MEDITEC AB P.O. BOX 14 S-4321 21 MOLNDAL Sweden, SE |
| Contact | Gosta Wennerstorm |
| Correspondent | Gosta Wennerstorm ASTRA MEDITEC AB P.O. BOX 14 S-4321 21 MOLNDAL Sweden, SE |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-24 |
| Decision Date | 1993-03-24 |