The following data is part of a premarket notification filed by Semperit Technische Produkte Gesellshaft with the FDA for Sempermed Derma Plus, Sizes 5.5,6,6.5,7,7.5,8,8.5,9.
| Device ID | K012819 |
| 510k Number | K012819 |
| Device Name: | SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 |
| 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 | 2001-08-23 |
| Decision Date | 2001-11-16 |
| Summary: | summary |