The following data is part of a premarket notification filed by Rymed Technologies, Inc. with the FDA for Slav And Slav-one Injection Port Connector System.
Device ID | K960771 |
510k Number | K960771 |
Device Name: | SLAV AND SLAV-ONE INJECTION PORT CONNECTOR SYSTEM |
Classification | Set, Administration, Intravascular |
Applicant | RYMED TECHNOLOGIES, INC. 3110 BLUE SAGE DR. Woodward, OK 73801 |
Contact | Dana W Ryan |
Correspondent | Dana W Ryan RYMED TECHNOLOGIES, INC. 3110 BLUE SAGE DR. Woodward, OK 73801 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-02-26 |
Decision Date | 1996-12-10 |
Summary: | summary |