The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Pain Control Infusion Pump.
| Device ID | K990101 |
| 510k Number | K990101 |
| Device Name: | PAIN CONTROL INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos, CA 95030 |
| Contact | Thomas Sgarlato |
| Correspondent | Thomas Sgarlato SGARLATO LABORATORIES, INC. 250 ALMENDRA AVE. Los Gatos, CA 95030 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-12 |
| Decision Date | 1999-03-19 |
| Summary: | summary |