The following data is part of a premarket notification filed by Sgarlato Laboratories, Inc. with the FDA for Sgarlato Labs Painfree Pump And Pain Control Infusion Pump.
| Device ID | K043204 |
| 510k Number | K043204 |
| Device Name: | SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP |
| Classification | Pump, Infusion |
| Applicant | SGARLATO LABORATORIES, INC. 2315 SO. BASCOM QUALITY MANAGEMENT Campbell, CA 95008 |
| Contact | Michael Mcdougall |
| Correspondent | Michael Mcdougall SGARLATO LABORATORIES, INC. 2315 SO. BASCOM QUALITY MANAGEMENT Campbell, CA 95008 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-18 |
| Decision Date | 2005-03-30 |
| Summary: | summary |