The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Safeset Reservoir.
| Device ID | K932188 |
| 510k Number | K932188 |
| Device Name: | SAFESET RESERVOIR |
| Classification | Catheter, Continuous Flush |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Frederick Gustafson |
| Correspondent | Frederick Gustafson ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-06 |
| Decision Date | 1993-10-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840619033559 | K932188 | 000 |
| 10887709042527 | K932188 | 000 |
| 10887709042480 | K932188 | 000 |
| 10840619068957 | K932188 | 000 |
| 10840619044234 | K932188 | 000 |
| 10840619044166 | K932188 | 000 |
| 10887709052281 | K932188 | 000 |
| 10887709078410 | K932188 | 000 |
| 10840619030312 | K932188 | 000 |
| 10887709042534 | K932188 | 000 |
| 10887709043494 | K932188 | 000 |
| 10887709044163 | K932188 | 000 |
| 10887709084077 | K932188 | 000 |
| 10887709060378 | K932188 | 000 |
| 10887709060330 | K932188 | 000 |
| 10887709052366 | K932188 | 000 |
| 10887709050867 | K932188 | 000 |
| 10887709050676 | K932188 | 000 |
| 10887709046150 | K932188 | 000 |
| 10887709045825 | K932188 | 000 |
| 10887709044026 | K932188 | 000 |