The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt New Beginnings Gelshapes & Amend.
| Device ID | K972597 |
| 510k Number | K972597 |
| Device Name: | PMT NEW BEGINNINGS GELSHAPES & AMEND |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Contact | Stephen M Trinter |
| Correspondent | Stephen M Trinter PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-11 |
| Decision Date | 1997-10-01 |
| Summary: | summary |