The following data is part of a premarket notification filed by Wells Johnson Co. with the FDA for Wells Johnson Infusion System, Model 20-6000-00.
| Device ID | K991437 |
| 510k Number | K991437 |
| Device Name: | WELLS JOHNSON INFUSION SYSTEM, MODEL 20-6000-00 |
| Classification | Pump, Infusion |
| Applicant | WELLS JOHNSON CO. 8000 SOUTH KOLB RD. Tucson, AZ 85706 |
| Contact | Ken Rodenburg |
| Correspondent | Ken Rodenburg WELLS JOHNSON CO. 8000 SOUTH KOLB RD. Tucson, AZ 85706 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-26 |
| Decision Date | 1999-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B458206200000 | K991437 | 000 |
| B458206000000 | K991437 | 000 |