The following data is part of a premarket notification filed by Ryan Medical, Inc. with the FDA for Shamrock Safety Blood Collection Set.
| Device ID | K895705 |
| 510k Number | K895705 |
| Device Name: | SHAMROCK SAFETY BLOOD COLLECTION SET |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-11 |
| Decision Date | 1989-10-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10351688060495 | K895705 | 000 |
| 30351688060000 | K895705 | 000 |
| 30351688060505 | K895705 | 000 |
| 10351688060518 | K895705 | 000 |
| 10351688060549 | K895705 | 000 |
| 10351688060556 | K895705 | 000 |
| 30351688081753 | K895705 | 000 |
| 10351688081766 | K895705 | 000 |
| 10351688081773 | K895705 | 000 |
| 10351688081780 | K895705 | 000 |
| 10351688081797 | K895705 | 000 |
| 30351688059974 | K895705 | 000 |
| 10351688059987 | K895705 | 000 |
| 10351688060440 | K895705 | 000 |
| 30351688060451 | K895705 | 000 |
| 10351688060488 | K895705 | 000 |
| 30351688059998 | K895705 | 000 |