The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Medical Reprocessed Aircast Venaflow Calf Garments/all Sizes, Renu Medical Reprocessed Aircast Venaflow Thigh Garme.
| Device ID | K121145 |
| 510k Number | K121145 |
| Device Name: | RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME |
| Classification | Sleeve, Limb, Compressible |
| Applicant | RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Contact | Bruce Pierson |
| Correspondent | Bruce Pierson 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 | 2012-04-16 |
| Decision Date | 2012-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10861317022980 | K121145 | 000 |
| 10816317020016 | K121145 | 000 |
| 10816317020023 | K121145 | 000 |
| 10816317020030 | K121145 | 000 |
| 10816317020429 | K121145 | 000 |
| 10816317022980 | K121145 | 000 |
| 10861317020009 | K121145 | 000 |
| 10861317020016 | K121145 | 000 |
| 10861317020023 | K121145 | 000 |
| 10861317020030 | K121145 | 000 |
| 10861317020429 | K121145 | 000 |
| 10816317020009 | K121145 | 000 |