The following data is part of a premarket notification filed by Currie Medical Specialties, Inc. with the FDA for Alp 501 Rb Pump System.
Device ID | K112311 |
510k Number | K112311 |
Device Name: | ALP 501 RB PUMP SYSTEM |
Classification | Sleeve, Limb, Compressible |
Applicant | CURRIE MEDICAL SPECIALTIES, INC. 730 EAST LOS ANGELES AVE. Monrovia, CA 91016 |
Contact | Bernice Navarro |
Correspondent | Bernice Navarro CURRIE MEDICAL SPECIALTIES, INC. 730 EAST LOS ANGELES AVE. Monrovia, CA 91016 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-11 |
Decision Date | 2011-09-01 |
Summary: | summary |