The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard V-max Roller Bar (3551xx;xx=01,02,03,04,05, Or 06).
| Device ID | K961841 |
| 510k Number | K961841 |
| Device Name: | BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) |
| Classification | Electrode, Electrosurgical, Active, Urological |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Evans Yi-wen Wuu |
| Correspondent | Evans Yi-wen Wuu C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | FAS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-13 |
| Decision Date | 1996-10-09 |
| Summary: | summary |