The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Medical Reprocessed Alp 1 Calf Garment, Model Alp1.
| Device ID | K051227 |
| 510k Number | K051227 |
| Device Name: | RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Contact | George Biggins |
| Correspondent | George Biggins RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-12 |
| Decision Date | 2006-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10861317020290 | K051227 | 000 |
| 10816317020115 | K051227 | 000 |
| 10816317020122 | K051227 | 000 |
| 10816317020139 | K051227 | 000 |
| 10816317020146 | K051227 | 000 |
| 10816317020153 | K051227 | 000 |
| 10816317020160 | K051227 | 000 |
| 10816317020290 | K051227 | 000 |
| 10861317020108 | K051227 | 000 |
| 10861317020115 | K051227 | 000 |
| 10861317020122 | K051227 | 000 |
| 10861317020139 | K051227 | 000 |
| 10861317020146 | K051227 | 000 |
| 10861317020153 | K051227 | 000 |
| 10861317020160 | K051227 | 000 |
| 10816317020108 | K051227 | 000 |