The following data is part of a premarket notification filed by Selicor, Inc. with the FDA for Selitherm, Model C100.
Device ID | K030382 |
510k Number | K030382 |
Device Name: | SELITHERM, MODEL C100 |
Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
Applicant | SELICOR, INC. 7000 NORTH MOPAC, SECOND FLR. Austin, TX 78731 |
Contact | James B Bingham |
Correspondent | James B Bingham SELICOR, INC. 7000 NORTH MOPAC, SECOND FLR. Austin, TX 78731 |
Product Code | IMJ |
CFR Regulation Number | 890.5290 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-05 |
Decision Date | 2003-04-01 |