The following data is part of a premarket notification filed by Coolanalgesia Ltd. with the FDA for Coolan 300.
Device ID | K030810 |
510k Number | K030810 |
Device Name: | COOLAN 300 |
Classification | Powered Laser Surgical Instrument |
Applicant | COOLANALGESIA LTD. WILLIAM GATES BUILDING 15 J.J. THOMSON AVENUE Cambridge, England, GB Cb3 0fd |
Contact | Peter Wilkinson |
Correspondent | Pamela Gwynn UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2003-03-13 |
Decision Date | 2004-05-05 |