The following data is part of a premarket notification filed by Salt Creek Medical Technologies with the FDA for S.c.t. Multi Port, Injection Site.
Device ID | K864296 |
510k Number | K864296 |
Device Name: | S.C.T. MULTI PORT, INJECTION SITE |
Classification | Set, Administration, Intravascular |
Applicant | SALT CREEK MEDICAL TECHNOLOGIES 5509 MIDDLETOWN RD. Canfield, OH 44406 |
Contact | Howard Meade |
Correspondent | Howard Meade SALT CREEK MEDICAL TECHNOLOGIES 5509 MIDDLETOWN RD. Canfield, OH 44406 |
Product Code | FPA |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-31 |
Decision Date | 1987-03-02 |