The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Dvt60.
Device ID | K022786 |
510k Number | K022786 |
Device Name: | DVT60 |
Classification | Sleeve, Limb, Compressible |
Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
Contact | Audrey Witko |
Correspondent | Audrey Witko HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-08-22 |
Decision Date | 2002-09-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15055982700747 | K022786 | 000 |