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 |