The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Thermal Regulation System Blanket.
| Device ID | K964377 |
| 510k Number | K964377 |
| Device Name: | THERMAL REGULATION SYSTEM BLANKET |
| Classification | System, Thermal Regulating |
| Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Contact | Elaine M Heazeltine |
| Correspondent | Elaine M Heazeltine GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-04-23 |