The following data is part of a premarket notification filed by King & Spalding with the FDA for Implantech Medical Grade Silicone Sheeting.
| Device ID | K944408 |
| 510k Number | K944408 |
| Device Name: | IMPLANTECH MEDICAL GRADE SILICONE SHEETING |
| Classification | Elastomer, Silicone Block |
| Applicant | KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
| Contact | Edward M Basile |
| Correspondent | Edward M Basile KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington, DC 20006 -4706 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-08 |
| Decision Date | 1994-11-09 |