The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for New Use For Acuvac Suction Reservoir 400cc.
| Device ID | K863201 |
| 510k Number | K863201 |
| Device Name: | NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC |
| Classification | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Applicant | ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Product Code | GCY |
| CFR Regulation Number | 878.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-19 |
| Decision Date | 1986-08-29 |