The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Cla Kit (continuous Local Anesthesia), Model 551-17, 551-10, 551-07.
| Device ID | K994059 |
| 510k Number | K994059 |
| Device Name: | CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 |
| Classification | Anesthesia Conduction Kit |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | James Abilla |
| Correspondent | James Abilla HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-29 |
| Decision Date | 2000-10-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B33955718150 | K994059 | 000 |
| B33955718090 | K994059 | 000 |
| B33955718055 | K994059 | 000 |