The following data is part of a premarket notification filed by Sarstedt, Inc. with the FDA for Safety-multifly.
| Device ID | K032150 |
| 510k Number | K032150 |
| Device Name: | SAFETY-MULTIFLY |
| Classification | Set, Administration, Intravascular |
| Applicant | SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. PO BOX 468 Newton, NC 28658 |
| Contact | Peter Rumswinkel |
| Correspondent | Peter Rumswinkel SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. PO BOX 468 Newton, NC 28658 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-14 |
| Decision Date | 2003-09-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852714003194 | K032150 | 000 |