The following data is part of a premarket notification filed by Kmi Kolster Methods, Inc. with the FDA for Irrigation Or Infusion Pump K Pump.
| Device ID | K991203 |
| 510k Number | K991203 |
| Device Name: | IRRIGATION OR INFUSION PUMP K PUMP |
| Classification | Pump, Infusion |
| Applicant | KMI KOLSTER METHODS, INC. 2550 WEST ROWLAND AVE. Anaheim, CA 92804 |
| Contact | Alwin H Kolster |
| Correspondent | Alwin H Kolster KMI KOLSTER METHODS, INC. 2550 WEST ROWLAND AVE. Anaheim, CA 92804 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-08 |
| Decision Date | 1999-10-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851314007052 | K991203 | 000 |