The following data is part of a premarket notification filed by Haz-med, Inc. with the FDA for Trauma Sleeve.
| Device ID | K901509 |
| 510k Number | K901509 |
| Device Name: | TRAUMA SLEEVE |
| Classification | Bedding, Disposable, Medical |
| Applicant | HAZ-MED, INC. 233 FELCH ST. Holland, MI 49424 |
| Contact | David B Weeks |
| Correspondent | David B Weeks HAZ-MED, INC. 233 FELCH ST. Holland, MI 49424 |
| Product Code | KME |
| CFR Regulation Number | 880.6060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-30 |
| Decision Date | 1990-09-12 |