The following data is part of a premarket notification filed by Puritas Health Care, Inc. with the FDA for Op-flex Sump Suction Set With Diffuser Tip.
| Device ID | K935531 |
| 510k Number | K935531 |
| Device Name: | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP |
| Classification | Catheter, Irrigation |
| Applicant | PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Contact | Thomas P Dimaio |
| Correspondent | Thomas P Dimaio PURITAS HEALTH CARE, INC. 219 KENT RD. SUITE 20 New Milford, CT 06776 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-16 |
| Decision Date | 1994-05-05 |