The following data is part of a premarket notification filed by Renu Medical, Inc. with the FDA for Renu Medical Vasopress Calf , Thigh Garments- All Sizesd, Renu Medical Vasopress Foot Garments.
| Device ID | K093658 |
| 510k Number | K093658 |
| Device Name: | RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | RENU MEDICAL, INC. 9800 EVERGREEN WAY Everett, WA 98204 |
| Contact | L. Bruce Pierson |
| Correspondent | L. 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 | 2009-11-25 |
| Decision Date | 2010-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00861317022952 | K093658 | 000 |
| 10816317022942 | K093658 | 000 |
| 10816317020436 | K093658 | 000 |
| 10816317020412 | K093658 | 000 |
| 10816317020405 | K093658 | 000 |
| 10816317020399 | K093658 | 000 |
| 10816317020382 | K093658 | 000 |
| 10816317020375 | K093658 | 000 |
| 10816317020368 | K093658 | 000 |
| 10816317020351 | K093658 | 000 |
| 10816317020344 | K093658 | 000 |
| 00816317022952 | K093658 | 000 |
| 10861317020337 | K093658 | 000 |
| 10861317022942 | K093658 | 000 |
| 10861317020436 | K093658 | 000 |
| 10861317020412 | K093658 | 000 |
| 10861317020405 | K093658 | 000 |
| 10861317020399 | K093658 | 000 |
| 10861317020382 | K093658 | 000 |
| 10861317020375 | K093658 | 000 |
| 10861317020368 | K093658 | 000 |
| 10861317020351 | K093658 | 000 |
| 10861317020344 | K093658 | 000 |
| 10816317020337 | K093658 | 000 |