The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Davol Plume Filter (5541420).
| Device ID | K964211 |
| 510k Number | K964211 |
| Device Name: | DAVOL PLUME FILTER (5541420) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Christine Nichols |
| Correspondent | Christine Nichols DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-22 |
| Decision Date | 1996-12-02 |
| Summary: | summary |