The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed Compression Garment.
| Device ID | K012403 |
| 510k Number | K012403 |
| Device Name: | VANGUARD REPROCESSED COMPRESSION GARMENT |
| Classification | Sleeve, Limb, Compressible |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Contact | Michael Sammon |
| Correspondent | Michael Sammon VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-30 |
| Decision Date | 2001-10-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885825017229 | K012403 | 000 |
| 50885825016666 | K012403 | 000 |
| 50885825016727 | K012403 | 000 |
| 50885825016734 | K012403 | 000 |
| 50885825016741 | K012403 | 000 |
| 50885825016758 | K012403 | 000 |
| 50885825017113 | K012403 | 000 |
| 50885825017144 | K012403 | 000 |
| 50885825017151 | K012403 | 000 |
| 50885825017168 | K012403 | 000 |
| 50885825017175 | K012403 | 000 |
| 50885825017205 | K012403 | 000 |
| 50885825017212 | K012403 | 000 |
| 50885825013085 | K012403 | 000 |