The following data is part of a premarket notification filed by All-hands Medical Supply, Inc. with the FDA for All-hands Sterile Field-0201.
| Device ID | K842545 |
| 510k Number | K842545 |
| Device Name: | ALL-HANDS STERILE FIELD-0201 |
| Classification | Drape, Surgical |
| Applicant | ALL-HANDS MEDICAL SUPPLY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-02 |
| Decision Date | 1984-08-01 |