The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Heart-chill Saline Slush Pad.
Device ID | K882035 |
510k Number | K882035 |
Device Name: | HEART-CHILL SALINE SLUSH PAD |
Classification | System, Thermal Regulating |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | DWJ |
CFR Regulation Number | 870.5900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-16 |
Decision Date | 1988-07-28 |