The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Durasil I And Durasil Ii.
| Device ID | K973730 |
| 510k Number | K973730 |
| Device Name: | DURASIL I AND DURASIL II |
| Classification | Elastomer, Silicone Block |
| Applicant | HANSON MEDICAL, INC. 19325 58TH PLACE, N.E. Seattle, WA 98155 |
| Contact | Gerald Hanson |
| Correspondent | Gerald Hanson HANSON MEDICAL, INC. 19325 58TH PLACE, N.E. Seattle, WA 98155 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-30 |
| Decision Date | 1997-12-24 |
| Summary: | summary |