The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Leep Redikit.
Device ID | K910253 |
510k Number | K910253 |
Device Name: | LEEP REDIKIT |
Classification | Set, Anesthesia, Paracervical |
Applicant | COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
Contact | Charles L Rose |
Correspondent | Charles L Rose COOPERSURGICAL, INC. C/O CHARLES I. ROSE & CO., INC 1963 ROCK STREET, SUITE #17 Mountain View, CA 94043 |
Product Code | HEE |
CFR Regulation Number | 884.5100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-22 |
Decision Date | 1991-04-18 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20888937011191 | K910253 | 000 |
00888937000030 | K910253 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LEEP REDIKIT 74144654 1800611 Live/Registered |
CooperSurgical, Inc. 1991-03-05 |