The following data is part of a premarket notification filed by Osteogenics, Inc. with the FDA for Star Temporary Wound Cover.
| Device ID | K983753 |
| 510k Number | K983753 |
| Device Name: | STAR TEMPORARY WOUND COVER |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | OSTEOGENICS, INC. 7781 LAKEVIEW DR. Burlington, WI 53105 -8119 |
| Contact | Michael Deutsch |
| Correspondent | Michael Deutsch OSTEOGENICS, INC. 7781 LAKEVIEW DR. Burlington, WI 53105 -8119 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-16 |
| Decision Date | 1999-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810805000187 | K983753 | 000 |