The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Sur Flo Thermal Therapy Pads.
Device ID | K930634 |
510k Number | K930634 |
Device Name: | SUR FLO THERMAL THERAPY PADS |
Classification | Pack, Hot Or Cold, Water Circulating |
Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Product Code | ILO |
CFR Regulation Number | 890.5720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-08 |
Decision Date | 1993-11-01 |