The following data is part of a premarket notification filed by Pmt Corp. with the FDA for Pmt(r) Silicone Gel Sheeting Model 3505-1.
| Device ID | K930409 |
| 510k Number | K930409 |
| Device Name: | PMT(R) SILICONE GEL SHEETING MODEL 3505-1 |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | PMT CORP. 1500 PARK RD. Chanhassen, MN 55317 |
| Contact | Timothy Keeter |
| Correspondent | Timothy Keeter 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 | 1993-01-26 |
| Decision Date | 1993-09-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20650551093620 | K930409 | 000 |
| 10650551093623 | K930409 | 000 |
| 10650551093630 | K930409 | 000 |
| 10650551093647 | K930409 | 000 |
| 10650551093654 | K930409 | 000 |
| 10650551093661 | K930409 | 000 |
| 10650551093678 | K930409 | 000 |
| 10650551093685 | K930409 | 000 |
| 10650551093692 | K930409 | 000 |
| 20650551093613 | K930409 | 000 |
| 10650551093616 | K930409 | 000 |