The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Swank Blood Transfusion Micro-filter W/straight Se.
| Device ID | K855064 |
| 510k Number | K855064 |
| Device Name: | SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE |
| Classification | Microfilter, Blood Transfusion |
| Applicant | COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Contact | Vera Buffaloe |
| Correspondent | Vera Buffaloe COBE LABORATORIES, INC. 1185 OAK ST. Lakewood, CO 80215 |
| Product Code | CAK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-18 |
| Decision Date | 1986-03-12 |