The following data is part of a premarket notification filed by Currie Medical Specialties, Inc. with the FDA for Alp Vasqcare Take Home System.
Device ID | K151158 |
510k Number | K151158 |
Device Name: | ALP VasQcare Take Home System |
Classification | Sleeve, Limb, Compressible |
Applicant | Currie Medical Specialties, Inc. 8758 Hellman Ave Rancho Cucamonga, CA 91730 |
Contact | Owen J Bry |
Correspondent | Owen J Bry Currie Medical Specialties, Inc. 8758 Hellman Ave Rancho Cucamonga, CA 91730 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-05-01 |
Decision Date | 2015-12-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857910006451 | K151158 | 000 |
00857910006437 | K151158 | 000 |
00857910006154 | K151158 | 000 |