The following data is part of a premarket notification filed by Davol, Inc., Sub. C.r. Bard, Inc. with the FDA for Simpulse Solo Suction Irrigator.
| Device ID | K942886 |
| 510k Number | K942886 |
| Device Name: | SIMPULSE SOLO SUCTION IRRIGATOR |
| Classification | Lavage, Jet |
| Applicant | DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Contact | Annette M Fagnant |
| Correspondent | Annette M Fagnant DAVOL, INC., SUB. C.R. BARD, INC. 100 SOCKANOSSETT CROSSROAD Cranston, RI 02920 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-17 |
| Decision Date | 1994-07-19 |