The following data is part of a premarket notification filed by Ram Development with the FDA for Stopcock.
Device ID | K862691 |
510k Number | K862691 |
Device Name: | STOPCOCK |
Classification | Stopcock, I.v. Set |
Applicant | RAM DEVELOPMENT 28 REMEZ ST NES-ZIONA 70400 Israel, IL |
Contact | Itzik Rabinovitz |
Correspondent | Itzik Rabinovitz RAM DEVELOPMENT 28 REMEZ ST NES-ZIONA 70400 Israel, IL |
Product Code | FMG |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-15 |
Decision Date | 1986-07-28 |