The following data is part of a premarket notification filed by Gibeck, Inc. with the FDA for Gibeck Warmbag Reusable Convective Warming Blanket.
| Device ID | K960511 |
| 510k Number | K960511 |
| Device Name: | GIBECK WARMBAG REUSABLE CONVECTIVE WARMING BLANKET |
| Classification | System, Thermal Regulating |
| Applicant | GIBECK, INC. 10640 EAST 59TH ST. P.O. BOX 36430 Indianapolis, IN 46236 |
| Contact | Brian Grigsby |
| Correspondent | Brian Grigsby 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 | 1996-02-05 |
| Decision Date | 1997-01-13 |
| Summary: | summary |