The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Modification To Arthrocare Perc-d Spinewand.
Device ID | K061259 |
510k Number | K061259 |
Device Name: | MODIFICATION TO ARTHROCARE PERC-D SPINEWAND |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
Contact | Valerie Defiesta-ng |
Correspondent | Valerie Defiesta-ng ARTHROCARE CORP. 680 VAQUEROS AVE. Sunnyvale, CA 94085 -3523 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-05-05 |
Decision Date | 2006-05-18 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060696460095 | K061259 | 000 |
05060696460088 | K061259 | 000 |
05060696460071 | K061259 | 000 |
05060696460064 | K061259 | 000 |
05060696460026 | K061259 | 000 |
05060696460019 | K061259 | 000 |
05060696460002 | K061259 | 000 |