The following data is part of a premarket notification filed by Sun Scientific Llc with the FDA for Sun Scientific Llc-leg Compressor And Pfab.
| Device ID | K070457 |
| 510k Number | K070457 |
| Device Name: | SUN SCIENTIFIC LLC-LEG COMPRESSOR AND PFAB |
| Classification | Dressing, Compression |
| Applicant | SUN SCIENTIFIC LLC 543 LONG HILL AVENUE Shelton, CT 06484 |
| Contact | Joseph Azary |
| Correspondent | Joseph Azary SUN SCIENTIFIC LLC 543 LONG HILL AVENUE Shelton, CT 06484 |
| Product Code | MHW |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-16 |
| Decision Date | 2007-05-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856525007051 | K070457 | 000 |
| 00856525007419 | K070457 | 000 |
| 00856525007310 | K070457 | 000 |
| 00856525007297 | K070457 | 000 |
| 00856525007273 | K070457 | 000 |
| 00856525007259 | K070457 | 000 |
| 00856525007198 | K070457 | 000 |
| 00856525007174 | K070457 | 000 |
| 00856525007143 | K070457 | 000 |
| 00856525007136 | K070457 | 000 |
| 00856525007556 | K070457 | 000 |
| 00856525007532 | K070457 | 000 |
| 00856525007518 | K070457 | 000 |
| 00856525007495 | K070457 | 000 |
| 00856525007488 | K070457 | 000 |
| 00856525007464 | K070457 | 000 |
| 00856525007440 | K070457 | 000 |
| 00856525007457 | K070457 | 000 |
| 00856525007068 | K070457 | 000 |
| 00856525007075 | K070457 | 000 |
| 00856525007037 | K070457 | 000 |
| 00856525007020 | K070457 | 000 |
| 00856525007013 | K070457 | 000 |
| 00856525007006 | K070457 | 000 |
| 00856525007396 | K070457 | 000 |
| 00856525007389 | K070457 | 000 |
| 00856525007372 | K070457 | 000 |
| 00856525007365 | K070457 | 000 |
| 00856525007303 | K070457 | 000 |
| 00856525007280 | K070457 | 000 |
| 00856525007266 | K070457 | 000 |
| 00856525007242 | K070457 | 000 |
| 00856525007228 | K070457 | 000 |
| 00856525007204 | K070457 | 000 |
| 00856525007181 | K070457 | 000 |
| 00856525007167 | K070457 | 000 |
| 00856525007426 | K070457 | 000 |