The following data is part of a premarket notification filed by Aesthetic And Reconstructive Technologies, Inc. with the FDA for Aart Silicone Sheeting.
Device ID | K022223 |
510k Number | K022223 |
Device Name: | AART SILICONE SHEETING |
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 | 2002-07-09 |
Decision Date | 2002-08-08 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B4902016640B0 | K022223 | 000 |
B4902006630A0 | K022223 | 000 |
B49020066308A0 | K022223 | 000 |
B4902006620A0 | K022223 | 000 |
B49020066208A0 | K022223 | 000 |
B4902006610A0 | K022223 | 000 |
B49020066108A0 | K022223 | 000 |
B4902006605B0 | K022223 | 000 |
B4902006605A0 | K022223 | 000 |
B49020066058A0 | K022223 | 000 |
B4902003340A1 | K022223 | 000 |
B4902003330A1 | K022223 | 000 |
B4902003320B1 | K022223 | 000 |
B4902003310B1 | K022223 | 000 |
B4902003305B1 | K022223 | 000 |
B49020066408A0 | K022223 | 000 |
B4902006640A0 | K022223 | 000 |
B4902011220B0 | K022223 | 000 |
B4902016640A0 | K022223 | 000 |
B49020166408A0 | K022223 | 000 |
B4902016630A0 | K022223 | 000 |
B49020166308A0 | K022223 | 000 |
B4902016620A0 | K022223 | 000 |
B49020166208A0 | K022223 | 000 |
B4902016610A0 | K022223 | 000 |
B49020166108A0 | K022223 | 000 |
B4902013340B1 | K022223 | 000 |
B4902013330A1 | K022223 | 000 |
B4902013320A1 | K022223 | 000 |
B4902013310A1 | K022223 | 000 |
B4902011240B0 | K022223 | 000 |
B4902011230B0 | K022223 | 000 |
B4902001205A0 | K022223 | 000 |