The following data is part of a premarket notification filed by Aplicare, Inc. with the FDA for Sterile Saline - For Suction Catheter Lubrication.
| Device ID | K895039 |
| 510k Number | K895039 |
| Device Name: | STERILE SALINE - FOR SUCTION CATHETER LUBRICATION |
| Classification | Apparatus, Suction, Operating-room, Wall Vacuum Powered |
| Applicant | APLICARE, INC. 7 ORCHARD PARK RD. Madison, CT 06443 |
| Contact | Paul G Buccetti |
| Correspondent | Paul G Buccetti APLICARE, INC. 7 ORCHARD PARK RD. Madison, CT 06443 |
| Product Code | GCX |
| CFR Regulation Number | 880.6740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-09 |
| Decision Date | 1989-10-03 |