The following data is part of a premarket notification filed by Gainor Medical Europe, Ltd. with the FDA for I.v. Priming Set.
| Device ID | K913333 |
| 510k Number | K913333 |
| Device Name: | I.V. PRIMING SET |
| Classification | Set, Administration, Intravascular |
| Applicant | GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Contact | Mark Gainor |
| Correspondent | Mark Gainor GAINOR MEDICAL EUROPE, LTD. P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-26 |
| Decision Date | 1991-10-23 |