AUTOFUSER
Pump, Infusion, Elastomeric
ACE MEDICAL US, LLC
The following data is part of a premarket notification filed by Ace Medical Us, Llc with the FDA for Autofuser.
Pre-market Notification Details
| Device ID | K060258 |
| 510k Number | K060258 |
| Device Name: | AUTOFUSER |
| Classification | Pump, Infusion, Elastomeric |
| Applicant | ACE MEDICAL US, LLC 9102 TURFWAY BEND DR. Powell, OH 43065 -8497 |
| Contact | Andy Lamborne |
| Correspondent | Andy Lamborne ACE MEDICAL US, LLC 9102 TURFWAY BEND DR. Powell, OH 43065 -8497 |
| Product Code | MEB |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-01 |
| Decision Date | 2006-05-30 |
| Summary: | summary |
Trademark Results [AUTOFUSER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUTOFUSER 78314618 2961358 Live/Registered |
Ace Medical Co., Ltd. 2003-10-16 |
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