The following data is part of a premarket notification filed by T-scientific, Inc. with the FDA for T-scientific T-pad.
Device ID | K030334 |
510k Number | K030334 |
Device Name: | T-SCIENTIFIC T-PAD |
Classification | Dressing, Wound, Drug |
Applicant | T-SCIENTIFIC, INC. 1146 GARDENCREST LN. Houston, TX 77077 |
Contact | Dennis Metcalf |
Correspondent | Dennis Metcalf T-SCIENTIFIC, INC. 1146 GARDENCREST LN. Houston, TX 77077 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-01-31 |
Decision Date | 2003-04-21 |
Summary: | summary |