The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Duralastic Anatomical Nasal Implants.
| Device ID | K973573 |
| 510k Number | K973573 |
| Device Name: | DURALASTIC ANATOMICAL NASAL IMPLANTS |
| Classification | Prosthesis, Nose, Internal |
| Applicant | HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Contact | Hudson |
| Correspondent | Hudson HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Product Code | FZE |
| CFR Regulation Number | 878.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-19 |
| Decision Date | 1997-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B049N2S0 | K973573 | 000 |
| B049N151F0 | K973573 | 000 |
| B049N14W0 | K973573 | 000 |
| B049N14S0 | K973573 | 000 |
| B049N14F0 | K973573 | 000 |
| B049N138S0 | K973573 | 000 |
| B049N138F0 | K973573 | 000 |
| B049N137S0 | K973573 | 000 |
| B049N137F0 | K973573 | 000 |
| B049N136S0 | K973573 | 000 |
| B049N136F0 | K973573 | 000 |
| B049N151S0 | K973573 | 000 |
| B049N151W0 | K973573 | 000 |
| B049N2F0 | K973573 | 000 |
| B049N1W0 | K973573 | 000 |
| B049N1S0 | K973573 | 000 |
| B049N1F0 | K973573 | 000 |
| B049N16W0 | K973573 | 000 |
| B049N16S0 | K973573 | 000 |
| B049N16F0 | K973573 | 000 |
| B049N152W0 | K973573 | 000 |
| B049N152S0 | K973573 | 000 |
| B049N152F0 | K973573 | 000 |
| B049N135S0 | K973573 | 000 |
| B049N135F0 | K973573 | 000 |
| B049N121S0 | K973573 | 000 |
| B049N121F0 | K973573 | 000 |
| B049N11W0 | K973573 | 000 |
| B049N11S0 | K973573 | 000 |
| B049N11F0 | K973573 | 000 |
| B049N102W0 | K973573 | 000 |
| B049N102S0 | K973573 | 000 |
| B049N102F0 | K973573 | 000 |
| B049N101W0 | K973573 | 000 |
| B049N101S0 | K973573 | 000 |
| B049N121W0 | K973573 | 000 |
| B049N122F0 | K973573 | 000 |
| B049N134S0 | K973573 | 000 |
| B049N134F0 | K973573 | 000 |
| B049N133S0 | K973573 | 000 |
| B049N133F0 | K973573 | 000 |
| B049N132S0 | K973573 | 000 |
| B049N132F0 | K973573 | 000 |
| B049N131S0 | K973573 | 000 |
| B049N131F0 | K973573 | 000 |
| B049N122W0 | K973573 | 000 |
| B049N122S0 | K973573 | 000 |
| B049N101F0 | K973573 | 000 |
| B049V5W0 | K973573 | 000 |
| B049V1S0 | K973573 | 000 |
| B049V1F0 | K973573 | 000 |
| B049ND14S0 | K973573 | 000 |
| B049ND14F0 | K973573 | 000 |
| B049ND13S0 | K973573 | 000 |
| B049ND13F0 | K973573 | 000 |
| B049ND12S0 | K973573 | 000 |
| B049ND12F0 | K973573 | 000 |
| B049ND11S0 | K973573 | 000 |
| B049ND11F0 | K973573 | 000 |
| B049V1W0 | K973573 | 000 |
| B049V2F0 | K973573 | 000 |
| B049V5S0 | K973573 | 000 |
| B049V5F0 | K973573 | 000 |
| B049V4W0 | K973573 | 000 |
| B049V4S0 | K973573 | 000 |
| B049V4F0 | K973573 | 000 |
| B049V3W0 | K973573 | 000 |
| B049V3S0 | K973573 | 000 |
| B049V3F0 | K973573 | 000 |
| B049V2W0 | K973573 | 000 |
| B049V2S0 | K973573 | 000 |
| B049N9W0 | K973573 | 000 |
| B049N9S0 | K973573 | 000 |
| B049N6F0 | K973573 | 000 |
| B049N5W0 | K973573 | 000 |
| B049N5S0 | K973573 | 000 |
| B049N5F0 | K973573 | 000 |
| B049N4W0 | K973573 | 000 |
| B049N4S0 | K973573 | 000 |
| B049N4F0 | K973573 | 000 |
| B049N3W0 | K973573 | 000 |
| B049N3S0 | K973573 | 000 |
| B049N3F0 | K973573 | 000 |
| B049N6S0 | K973573 | 000 |
| B049N6W0 | K973573 | 000 |
| B049N9F0 | K973573 | 000 |
| B049N8W0 | K973573 | 000 |
| B049N8S0 | K973573 | 000 |
| B049N8F0 | K973573 | 000 |
| B049N72W0 | K973573 | 000 |
| B049N72S0 | K973573 | 000 |
| B049N72F0 | K973573 | 000 |
| B049N71W0 | K973573 | 000 |
| B049N71S0 | K973573 | 000 |
| B049N71F0 | K973573 | 000 |
| B049N2W0 | K973573 | 000 |