The following data is part of a premarket notification filed by Teleflex, Inc. with the FDA for Continuous Peripheral Nerve Block Catheter Kit And Set.
Device ID | K121403 |
510k Number | K121403 |
Device Name: | CONTINUOUS PERIPHERAL NERVE BLOCK CATHETER KIT AND SET |
Classification | Anesthesia Conduction Kit |
Applicant | TELEFLEX, INC. 2400 BERNVILLE ROAD Reading, PA 19605 |
Contact | Paul Amudala |
Correspondent | Paul Amudala TELEFLEX, INC. 2400 BERNVILLE ROAD Reading, PA 19605 |
Product Code | CAZ |
CFR Regulation Number | 868.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-05-10 |
Decision Date | 2012-06-20 |
Summary: | summary |