The following data is part of a premarket notification filed by Human Biosciences, Inc. with the FDA for Skintemp Ii.
| Device ID | K122325 |
| 510k Number | K122325 |
| Device Name: | SKINTEMP II |
| Classification | Dressing, Wound, Collagen |
| Applicant | HUMAN BIOSCIENCES, INC. 2913, 209TH LANE NW Oak Grove, MN 55011 |
| Contact | Jack Slovick |
| Correspondent | Jack Slovick HUMAN BIOSCIENCES, INC. 2913, 209TH LANE NW Oak Grove, MN 55011 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-01 |
| Decision Date | 2012-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004779804 | K122325 | 000 |
| 00850004779286 | K122325 | 000 |
| 00324357900449 | K122325 | 000 |
| 00324357900227 | K122325 | 000 |
| 10618474000524 | K122325 | 000 |