The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for J-vac Suction Reservoirs & J-vac Blake Silicone Drains.
| Device ID | K953655 |
| 510k Number | K953655 |
| Device Name: | J-VAC SUCTION RESERVOIRS & J-VAC BLAKE SILICONE DRAINS |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Contact | William P Robb |
| Correspondent | William P Robb JOHNSON & JOHNSON MEDICAL, INC. 2500 ARBROOK BLVD. P.O. BOX 90130 Arlington, TX 76004 -0130 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1995-10-13 |