The following data is part of a premarket notification filed by Capital Marketing Technologies, Inc. with the FDA for Nearly Me Retouch Silicone Scar Reduction Sheets.
| Device ID | K984213 |
| 510k Number | K984213 |
| Device Name: | NEARLY ME RETOUCH SILICONE SCAR REDUCTION SHEETS |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | CAPITAL MARKETING TECHNOLOGIES, INC. 3630 SOUTH I-35, SUITE A Waco, TX 76706 |
| Contact | John Snyder |
| Correspondent | John Snyder CAPITAL MARKETING TECHNOLOGIES, INC. 3630 SOUTH I-35, SUITE A Waco, TX 76706 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-24 |
| Decision Date | 1999-04-14 |
| Summary: | summary |