The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Implatech Rp Medical Grade Silicone Gel Sheeting.
| Device ID | K964846 |
| 510k Number | K964846 |
| Device Name: | IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING |
| Classification | Elastomer, Silicone, For Scar Management |
| Applicant | IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Contact | Edward M Basile, Esq. |
| Correspondent | Edward M Basile, Esq. IMPLANTECH ASSOCIATES, INC. 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 |
| Product Code | MDA |
| CFR Regulation Number | 878.4025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-02-12 |