The following data is part of a premarket notification filed by Semperit Technische Produkte Gesellshaft with the FDA for Sempermed Supreme, Sizes 5.5, 6, 6.5, 7, 7.5, 8, 8.5, And 9.
| Device ID | K013560 |
| 510k Number | K013560 |
| Device Name: | SEMPERMED SUPREME, SIZES 5.5, 6, 6.5, 7, 7.5, 8, 8.5, AND 9 |
| Classification | Surgeon's Gloves |
| Applicant | SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT 1308 MORNINGSTAR PARK DR. Apharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT 1308 MORNINGSTAR PARK DR. Apharetta, GA 30022 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-26 |
| Decision Date | 2002-01-16 |
| Summary: | summary |