The following data is part of a premarket notification filed by Scimed Life Systems, Inc. with the FDA for Scimed R30 Silicone Assist Reservoir.
Device ID | K882720 |
510k Number | K882720 |
Device Name: | SCIMED R30 SILICONE ASSIST RESERVOIR |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
Contact | Swanson Lano |
Correspondent | Swanson Lano SCIMED LIFE SYSTEMS, INC. 13000 COUNTY RD 6 Minneapolis, MN 55441 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-07-01 |
Decision Date | 1988-09-16 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
30613994010446 | K882720 | 000 |
30613994010439 | K882720 | 000 |