The following data is part of a premarket notification filed by Aci Medical, Llc with the FDA for Artassist And Venassist.
Device ID | K131146 |
510k Number | K131146 |
Device Name: | ARTASSIST AND VENASSIST |
Classification | Sleeve, Limb, Compressible |
Applicant | ACI MEDICAL, LLC 1857 DIAMOND ST San Marcos, CA 92078 |
Contact | Ed Arkans |
Correspondent | Ed Arkans ACI MEDICAL, LLC 1857 DIAMOND ST San Marcos, CA 92078 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-04-23 |
Decision Date | 2014-02-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860446000305 | K131146 | 000 |