The following data is part of a premarket notification filed by Target Health, Inc. with the FDA for Scar Care.
| Device ID | K971009 |
| 510k Number | K971009 |
| Device Name: | SCAR CARE |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | TARGET HEALTH, INC. 310 MADISON AVE. 22ND FLOOR New York, NY 10017 |
| Contact | Jules T Mitchel |
| Correspondent | Jules T Mitchel TARGET HEALTH, INC. 310 MADISON AVE. 22ND FLOOR New York, NY 10017 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-20 |
| Decision Date | 1997-07-29 |
| Summary: | summary |