The following data is part of a premarket notification filed by Healthcare Service And Supply with the FDA for Healthcare Service And Supply Pva (pneumatic Venous Augmentation) Foot Garment.
| Device ID | K964188 |
| 510k Number | K964188 |
| Device Name: | HEALTHCARE SERVICE AND SUPPLY PVA (PNEUMATIC VENOUS AUGMENTATION) FOOT GARMENT |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HEALTHCARE SERVICE AND SUPPLY P.O. BOX 1788 Tustin, CA 92681 |
| Contact | Rick Roeder |
| Correspondent | Rick Roeder HEALTHCARE SERVICE AND SUPPLY P.O. BOX 1788 Tustin, CA 92681 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-21 |
| Decision Date | 1997-05-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857910006635 | K964188 | 000 |
| 00857910006642 | K964188 | 000 |