The following data is part of a premarket notification filed by Mckinley, Inc. with the FDA for Modification To: Accufuser, Accufuser Plus, Standard Procedure Kits.
| Device ID | K033039 |
| 510k Number | K033039 |
| Device Name: | MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Contact | Andrew N Lamborne |
| Correspondent | Andrew N Lamborne MCKINLEY, INC. 4080 YOUNGFIELD ST. Wheat Ridge, CO 80033 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2003-10-07 |
| Summary: | summary |