The following data is part of a premarket notification filed by Johnson & Johnson Medical, Inc. with the FDA for J-vac Bulb Suction Reservoir.
| Device ID | K922895 |
| 510k Number | K922895 |
| Device Name: | J-VAC BULB SUCTION RESERVOIR |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Contact | T. M Wendt |
| Correspondent | T. M Wendt JOHNSON & JOHNSON MEDICAL, INC. P.O. BOX 90130 Arlington, TX 76004 -3130 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-16 |
| Decision Date | 1992-09-15 |