The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Silicone Carving Block.
| Device ID | K021820 |
| 510k Number | K021820 |
| Device Name: | AART SILICONE CARVING BLOCK |
| Classification | Elastomer, Silicone Block |
| Applicant | AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 5871 LONE PINE PLACE Paso Robles, CA 93446 |
| Contact | Catherine Riple |
| Correspondent | Catherine Riple AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 5871 LONE PINE PLACE Paso Robles, CA 93446 |
| Product Code | MIB |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-04 |
| Decision Date | 2002-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B4906006012C0 | K021820 | 000 |
| B4906006049A0 | K021820 | 000 |
| B490600604A0 | K021820 | 000 |
| B4906006052A0 | K021820 | 000 |
| B49060060532A0 | K021820 | 000 |
| B49060060539A0 | K021820 | 000 |
| B4906006059A0 | K021820 | 000 |
| B490600605A0 | K021820 | 000 |
| B49060070155108A0 | K021820 | 000 |
| B49060070155208A0 | K021820 | 000 |
| B49060070155308A0 | K021820 | 000 |
| B49060070155408A0 | K021820 | 000 |
| B49060070255108A0 | K021820 | 000 |
| B49060060439A0 | K021820 | 000 |
| B49060060432A0 | K021820 | 000 |
| B4906006042A0 | K021820 | 000 |
| B4906006019A0 | K021820 | 000 |
| B490600601B0 | K021820 | 000 |
| B4906006022C0 | K021820 | 000 |
| B49060060232A0 | K021820 | 000 |
| B49060060239A0 | K021820 | 000 |
| B4906006029A0 | K021820 | 000 |
| B490600602B0 | K021820 | 000 |
| B4906006032C0 | K021820 | 000 |
| B49060060332A0 | K021820 | 000 |
| B49060060339A0 | K021820 | 000 |
| B4906006039A0 | K021820 | 000 |
| B490600603B0 | K021820 | 000 |
| B49060070255208A0 | K021820 | 000 |
| B49060070255308A0 | K021820 | 000 |
| B49060070255408A0 | K021820 | 000 |
| B490600820A0 | K021820 | 000 |
| B4906008252A0 | K021820 | 000 |
| B490600825A0 | K021820 | 000 |
| B4906009012B0 | K021820 | 000 |
| B490600901B0 | K021820 | 000 |
| B4906009022B0 | K021820 | 000 |
| B4906009029A0 | K021820 | 000 |
| B490600902B0 | K021820 | 000 |
| B4906009032B0 | K021820 | 000 |
| B490600903B0 | K021820 | 000 |
| B4906009042B0 | K021820 | 000 |
| B490600904B0 | K021820 | 000 |
| B4906008202A0 | K021820 | 000 |
| B490600803A0 | K021820 | 000 |
| B4906008039A0 | K021820 | 000 |
| B49060070355108A0 | K021820 | 000 |
| B49060070355208A0 | K021820 | 000 |
| B49060070355308A0 | K021820 | 000 |
| B4906008012A0 | K021820 | 000 |
| B4906008012C0 | K021820 | 000 |
| B490600801A0 | K021820 | 000 |
| B490600801B0 | K021820 | 000 |
| B4906008022A0 | K021820 | 000 |
| B4906008029A0 | K021820 | 000 |
| B490600802A0 | K021820 | 000 |
| B490600802B0 | K021820 | 000 |
| B4906008032A0 | K021820 | 000 |
| B490600904C0 | K021820 | 000 |