The following data is part of a premarket notification filed by Selicor, Inc. with the FDA for Selicor, Models A100 & D100.
Device ID | K020227 |
510k Number | K020227 |
Device Name: | SELICOR, MODELS A100 & D100 |
Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
Applicant | SELICOR, INC. 515 EXTER #F7 San Antonio, TX 78209 |
Contact | James B Bingham |
Correspondent | James B Bingham SELICOR, INC. 515 EXTER #F7 San Antonio, TX 78209 |
Product Code | IMJ |
CFR Regulation Number | 890.5290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-01-22 |
Decision Date | 2002-07-30 |