The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Wavelinq™ Generator.
Device ID | K222793 |
510k Number | K222793 |
Device Name: | WavelinQ™ Generator |
Classification | Electrosurgical, Cutting & Coagulation & Accessories |
Applicant | C.R. Bard, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
Contact | Jakob Wells |
Correspondent | Jakob Wells C.R. Bard, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
Product Code | GEI |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-09-16 |
Decision Date | 2022-10-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00801741218033 | K222793 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
WAVELINQ 88021599 not registered Live/Pending |
C. R. BARD, INC. 2018-06-29 |