The following data is part of a premarket notification filed by Specialty Surgical Products, Inc. with the FDA for Sterile Silicone External Wound Cover.
| Device ID | K982065 |
| 510k Number | K982065 |
| Device Name: | STERILE SILICONE EXTERNAL WOUND COVER |
| Classification | Elastomer, Silicone Block |
| Applicant | SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| Contact | T. Jan Varner |
| Correspondent | T. Jan Varner SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. Hamilton, MT 59840 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-12 |
| Decision Date | 1998-08-12 |