The following data is part of a premarket notification filed by Ryan Medical, Inc. with the FDA for Shamrock Safety Winged Infusion Set.
| Device ID | K895481 |
| 510k Number | K895481 |
| Device Name: | SHAMROCK SAFETY WINGED INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | RYAN MEDICAL, INC. 7106 CROSSROADS BLVD. SUITE 201 Brentwood, TN 37027 |
| Contact | James M Kaiser |
| Correspondent | James M Kaiser RYAN MEDICAL, INC. 7106 CROSSROADS BLVD. SUITE 201 Brentwood, TN 37027 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-11 |
| Decision Date | 1989-10-10 |