The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Prn Adapter.
Device ID | K933467 |
510k Number | K933467 |
Device Name: | PRN ADAPTER |
Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET Sandy, UT 84070 |
Contact | Charles J Welle |
Correspondent | Charles J Welle BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 9450 SOUTH STATE SREET Sandy, UT 84070 |
Product Code | FOZ |
CFR Regulation Number | 880.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-07-16 |
Decision Date | 1994-12-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50382903851107 | K933467 | 000 |
50382903851145 | K933467 | 000 |
50382903851121 | K933467 | 000 |
50382903851114 | K933467 | 000 |