The following data is part of a premarket notification filed by Huntleigh Healthcare, Inc. with the FDA for Calf Garment Dvt10(s) Compressible Limb Sleeve.
| Device ID | K925717 |
| 510k Number | K925717 |
| Device Name: | CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HUNTLEIGH HEALTHCARE, INC. 40 CHRISTOPHER WAY Eatontown, NJ 07724 -3327 |
| Contact | Joann S Hegarty |
| Correspondent | Joann S Hegarty 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 | 1992-11-12 |
| Decision Date | 1993-05-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15055982700716 | K925717 | 000 |
| 15055982700686 | K925717 | 000 |