The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Perifix Pediatric Epidural Kit.
Device ID | K962696 |
510k Number | K962696 |
Device Name: | PERIFIX PEDIATRIC EPIDURAL KIT |
Classification | Anesthesia Conduction Kit |
Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Contact | Mark S Alsberge |
Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-11 |
Decision Date | 1997-04-03 |
Summary: | summary |