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 |