The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15.
| Device ID | K022752 |
| 510k Number | K022752 |
| Device Name: | PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15 |
| Classification | Anesthesia Conduction Kit |
| Applicant | HDC CORP. 628 GIBRALTAR COURT Milpitas, CA 95035 |
| Contact | Earl Smart |
| Correspondent | Earl Smart HDC CORP. 628 GIBRALTAR COURT Milpitas, CA 95035 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-19 |
| Decision Date | 2003-09-09 |
| Summary: | summary |