The following data is part of a premarket notification filed by Arthrocare Corp. with the FDA for Perc-d Spinewand.
Device ID | K010811 |
510k Number | K010811 |
Device Name: | PERC-D SPINEWAND |
Classification | Arthroscope |
Applicant | ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
Contact | Bruce Prothro |
Correspondent | Bruce Prothro ARTHROCARE CORP. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 -2936 |
Product Code | HRX |
CFR Regulation Number | 888.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-19 |
Decision Date | 2001-05-30 |