The following data is part of a premarket notification filed by Biolife, Llc with the FDA for Statseal Disc.
| Device ID | K130324 |
| 510k Number | K130324 |
| Device Name: | STATSEAL DISC |
| Classification | Dressing, Wound, Drug |
| Applicant | BIOLIFE, LLC 9163 25TH COURT EAST Sarasota, FL 34243 |
| Contact | Claudia Masselink |
| Correspondent | Claudia Masselink BIOLIFE, LLC 9163 25TH COURT EAST Sarasota, FL 34243 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-08 |
| Decision Date | 2013-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00834061000200 | K130324 | 000 |
| 00834061001238 | K130324 | 000 |
| 00834061000255 | K130324 | 000 |
| 00834061000132 | K130324 | 000 |
| 00834061000149 | K130324 | 000 |
| 00834061000156 | K130324 | 000 |
| 00834061000163 | K130324 | 000 |
| 00834061000170 | K130324 | 000 |
| 00834061000187 | K130324 | 000 |
| 00834061000194 | K130324 | 000 |
| 00834061000217 | K130324 | 000 |