The following data is part of a premarket notification filed by American Medical Systems, Inc. with the FDA for Coaguloop.
Device ID | K991314 |
510k Number | K991314 |
Device Name: | COAGULOOP |
Classification | Electrode, Electrosurgical, Active, Urological |
Applicant | AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
Contact | David Worrell |
Correspondent | David Worrell AMERICAN MEDICAL SYSTEMS, INC. 10700 BREN RD., WEST Minnetonka, MN 55343 |
Product Code | FAS |
CFR Regulation Number | 876.4300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-04-16 |
Decision Date | 1999-06-29 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COAGULOOP 75281821 2188559 Dead/Cancelled |
American Medical Systems, Inc. 1997-04-28 |