The following data is part of a premarket notification filed by Hanson Medical, Inc. with the FDA for Silicone Carving Block.
| Device ID | K973728 |
| 510k Number | K973728 |
| Device Name: | SILICONE CARVING BLOCK |
| Classification | Elastomer, Silicone Block |
| Applicant | HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| Contact | Erik Hanson |
| Correspondent | Erik Hanson HANSON MEDICAL, INC. P.O. BOX 1160 Kingston, WA 98346 |
| 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 | 1997-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B049BL2030W0 | K973728 | 000 |
| B049BL1330F0 | K973728 | 000 |
| B049BL1330C0 | K973728 | 000 |
| B049BL1325W0 | K973728 | 000 |
| B049BL1325F0 | K973728 | 000 |
| B049BL1325C0 | K973728 | 000 |
| B049BL1320W0 | K973728 | 000 |
| B049BL1320F0 | K973728 | 000 |
| B049BL1320C0 | K973728 | 000 |
| B049BL1315W0 | K973728 | 000 |
| B049BL1315F0 | K973728 | 000 |
| B049BL1315C0 | K973728 | 000 |
| B049BL1310W0 | K973728 | 000 |
| B049BL1310F0 | K973728 | 000 |
| B049BL1310C0 | K973728 | 000 |
| B049BL1305W0 | K973728 | 000 |
| B049BL1305F0 | K973728 | 000 |
| B049BL1330W0 | K973728 | 000 |
| B049BL2005C0 | K973728 | 000 |
| B049BL2030F0 | K973728 | 000 |
| B049BL2030C0 | K973728 | 000 |
| B049BL2025W0 | K973728 | 000 |
| B049BL2025F0 | K973728 | 000 |
| B049BL2025C0 | K973728 | 000 |
| B049BL2020W0 | K973728 | 000 |
| B049BL2020F0 | K973728 | 000 |
| B049BL2020C0 | K973728 | 000 |
| B049BL2015W0 | K973728 | 000 |
| B049BL2015F0 | K973728 | 000 |
| B049BL2015C0 | K973728 | 000 |
| B049BL2010W0 | K973728 | 000 |
| B049BL2010F0 | K973728 | 000 |
| B049BL2010C0 | K973728 | 000 |
| B049BL2005W0 | K973728 | 000 |
| B049BL2005F0 | K973728 | 000 |
| B049BL1305C0 | K973728 | 000 |