The following data is part of a premarket notification filed by Bz Medical Inc with the FDA for Calgaeseal Model: Cas.
| Device ID | K101097 |
| 510k Number | K101097 |
| Device Name: | CALGAESEAL MODEL: CAS |
| Classification | Dressing, Wound, Drug |
| Applicant | BZ MEDICAL INC 6611 SW BURLINGAME AVE Portland, OR 97239 |
| Contact | Byron Zahler |
| Correspondent | Byron Zahler BZ MEDICAL INC 6611 SW BURLINGAME AVE Portland, OR 97239 |
| 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 | 2010-04-20 |
| Decision Date | 2010-09-22 |
| Summary: | summary |