The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Dressing Change Kit.
| Device ID | K760912 |
| 510k Number | K760912 |
| Device Name: | DRESSING CHANGE KIT |
| Classification | Surgeon's Gloves |
| Applicant | AMERICAN HOSPITAL SUPPLY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-27 |
| Decision Date | 1976-12-02 |