The following data is part of a premarket notification filed by Seabrook Medical Systems, Inc. with the FDA for Electri-cool(tm) Liquid-circulat. Thermal Therapy.
Device ID | K902269 |
510k Number | K902269 |
Device Name: | ELECTRI-COOL(TM) LIQUID-CIRCULAT. THERMAL THERAPY |
Classification | Pack, Hot Or Cold, Water Circulating |
Applicant | SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
Contact | Mark J Buch |
Correspondent | Mark J Buch SEABROOK MEDICAL SYSTEMS, INC. 673 WILMER AVE. Cincinnati, OH 45226 -1859 |
Product Code | ILO |
CFR Regulation Number | 890.5720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-05-21 |
Decision Date | 1990-06-21 |