The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Hydroflex Hd Hysteroscopic Distention System,model #'s 0025360, 0025370, 0025000.
| Device ID | K982867 |
| 510k Number | K982867 |
| Device Name: | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 0025360, 0025370, 0025000 |
| Classification | Insufflator, Hysteroscopic |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Robin Drago |
| Correspondent | Robin Drago DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Product Code | HIG |
| CFR Regulation Number | 884.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-14 |
| Decision Date | 1999-02-19 |
| Summary: | summary |