The following data is part of a premarket notification filed by Epic Medical Pte. Ltd. with the FDA for Safety Subcutaneous Infusion Set.
| Device ID | K201626 |
| 510k Number | K201626 |
| Device Name: | Safety Subcutaneous Infusion Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Epic Medical Pte. Ltd. 105 Cecil Street #20-04 The Octagon Singapore, SG 069534 |
| Contact | Freddie Lee |
| Correspondent | Roshana Ahmed QUARAS, LLC 25 Independence Blvd. Warren, NJ 07059 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-16 |
| Decision Date | 2021-03-24 |