The following data is part of a premarket notification filed by Sterile Medical Systems with the FDA for Elastic Bandage.
| Device ID | K843056 |
| 510k Number | K843056 |
| Device Name: | ELASTIC BANDAGE |
| Classification | Tourniquet, Nonpneumatic |
| Applicant | STERILE MEDICAL SYSTEMS 541 MAIN STREET South Weymouth , MA 02190 - |
| Contact | George H Woodland |
| Correspondent | George H Woodland STERILE MEDICAL SYSTEMS 541 MAIN STREET South Weymouth , MA 02190 - |
| Product Code | GAX |
| CFR Regulation Number | 878.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-03 |
| Decision Date | 1984-12-04 |