The following data is part of a premarket notification filed by N.p. Medical, Inc. with the FDA for Np Medical Capless Luer Activated Valve.
| Device ID | K973916 |
| 510k Number | K973916 |
| Device Name: | NP MEDICAL CAPLESS LUER ACTIVATED VALVE |
| Classification | Set, Administration, Intravascular |
| Applicant | N.P. MEDICAL, INC. 101 UNION ST. Clinton, MA 01510 |
| Contact | Paul A Caracciolo |
| Correspondent | Paul A Caracciolo N.P. MEDICAL, INC. 101 UNION ST. Clinton, MA 01510 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-14 |
| Decision Date | 1998-03-09 |
| Summary: | summary |