The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Flowtron Universal, Model Ac600.
Device ID | K010744 |
510k Number | K010744 |
Device Name: | FLOWTRON UNIVERSAL, MODEL AC600 |
Classification | Sleeve, Limb, Compressible |
Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
Contact | Audry Witko |
Correspondent | Audry Witko HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-03-13 |
Decision Date | 2002-03-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05055982700146 | K010744 | 000 |
05055982700139 | K010744 | 000 |