The following data is part of a premarket notification filed by Med Technology, Inc. with the FDA for Bledsoe Cold Control.
Device ID | K964710 |
510k Number | K964710 |
Device Name: | BLEDSOE COLD CONTROL |
Classification | Pack, Hot Or Cold, Water Circulating |
Applicant | MED TECHNOLOGY, INC. 2601 PINEWOOD Grand Prairie, TX 75051 |
Contact | C. David Little |
Correspondent | C. David Little MED TECHNOLOGY, INC. 2601 PINEWOOD Grand Prairie, TX 75051 |
Product Code | ILO |
CFR Regulation Number | 890.5720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-25 |
Decision Date | 1997-05-09 |